The Tracker // October 2025
October 2025: 308 FDA device decisions
308 510(k) clearances and 0 original PMA approvals with a decision date in October 2025. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Oct 31, 25 | DEN240074510(k) | Pulsenmore ES | Pulsenmore, Ltd. | Radiology | SGJ |
| Oct 31, 25 | K250306510(k) | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | General Hospital | FRG |
| Oct 31, 25 | K250338510(k) | MSS - Humeral reverse liners extension | Medacta International S.A. | Orthopedic | PHX |
| Oct 31, 25 | K250358510(k) | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company | Microbiology | PCI |
| Oct 31, 25 | K250917510(k) | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Oct 31, 25 | K251041510(k) | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | Gastroenterology, Urology | FDS |
| Oct 31, 25 | K251381510(k) | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | Neurology | GXY |
| Oct 31, 25 | K251547510(k) | DESS Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Oct 31, 25 | K252060510(k) | GREEN | Phasor Health, LLC | Neurology | HBE |
| Oct 31, 25 | K252074510(k) | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Radiology | IYN |
| Oct 31, 25 | K252088510(k) | Firebird SI Navigation System | Orthofix US, LLC | Neurology | OLO |
| Oct 31, 25 | K252160510(k) | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | Neurology | OMB |
| Oct 31, 25 | K252412510(k) | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | General, Plastic Surgery | GEI |
| Oct 31, 25 | K252427510(k) | Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 31, 25 | K252442510(k) | Kii Structural Balloon Access System | Applied Medical Resources Corp. | Gastroenterology, Urology | GCJ |
| Oct 31, 25 | K252777510(k) | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | Orthopedic | MBH |
| Oct 31, 25 | K253501510(k) | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda | Dental | ELW |
| Oct 30, 25 | K243619510(k) | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | General, Plastic Surgery | ESW |
| Oct 30, 25 | K250325510(k) | BD Alaris Pump Infusion Set | Carefusion (Bd) | General Hospital | FPA |
| Oct 30, 25 | K250337510(k) | AiORTA - Plan | ViTAA Medical Solutions, Inc. | Radiology | QIH |
| Oct 30, 25 | K250632510(k) | Arctx Cool Catheter Set | Arctx Medical | Cardiovascular | PLA |
| Oct 30, 25 | K251531510(k) | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | Physical Medicine | IRP |
| Oct 30, 25 | K251686510(k) | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | Orthopedic | KWT |
| Oct 30, 25 | K251938510(k) | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | Dental | DZE |
| Oct 30, 25 | K252046510(k) | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | Cardiovascular | NRY |
| Oct 30, 25 | K252387510(k) | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC | Microbiology | QOF |
| Oct 30, 25 | K252414510(k) | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Physical Medicine | OAP |
| Oct 30, 25 | K252430510(k) | Freeprint® denture flex | Detax GmbH | Dental | EBI |
| Oct 30, 25 | K252529510(k) | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation | General, Plastic Surgery | GEX |
| Oct 30, 25 | K252607510(k) | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | Clinical Chemistry | JMT |
| Oct 30, 25 | K252752510(k) | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | General, Plastic Surgery | QAI |
| Oct 30, 25 | K253327510(k) | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | General, Plastic Surgery | ESW |
| Oct 30, 25 | K253376510(k) | OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation | Cardiovascular | KRD |
| Oct 29, 25 | K250316510(k) | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | Orthopedic | JDW |
| Oct 29, 25 | K250618510(k) | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Neurology | NFO |
| Oct 29, 25 | K250882510(k) | SANSA HSAT | Huxley Medical | Anesthesiology | MNR |
| Oct 29, 25 | K251643510(k) | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | Orthopedic | HTN |
| Oct 29, 25 | K251772510(k) | Navilas Laser System 577sl (156691) | Od-Os GmbH | Ophthalmic | HQF |
| Oct 29, 25 | K251963510(k) | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Oct 29, 25 | K251985510(k) | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Oct 29, 25 | K252314510(k) | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | Orthopedic | MBI |
| Oct 29, 25 | K252390510(k) | Telescope Guide Extension Catheter | Medtronic, Ireland | Cardiovascular | DQY |
| Oct 29, 25 | K252393510(k) | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | Clinical Chemistry | MMI |
| Oct 29, 25 | K252416510(k) | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | Orthopedic | KWS |
| Oct 29, 25 | K252697510(k) | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | Gastroenterology, Urology | GCJ |
| Oct 29, 25 | K253153510(k) | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | General, Plastic Surgery | QAI |
| Oct 29, 25 | K253232510(k) | Seguin Annuloplasty Ring | ABBOTT MEDICAL | Cardiovascular | KRH |
| Oct 29, 25 | K253242510(k) | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | Radiology | PGY |
| Oct 29, 25 | K253283510(k) | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 29, 25 | K253314510(k) | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Oct 29, 25 | K253323510(k) | Protrieve Sheath | Inari Medical | Cardiovascular | QEW |
| Oct 29, 25 | K253345510(k) | JARVIS Diaphyseal Stem Standard | FH Industrie | Orthopedic | PHX |
| Oct 29, 25 | K253355510(k) | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | Dental | LRK |
| Oct 28, 25 | K250275510(k) | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. | General, Plastic Surgery | GEI |
| Oct 28, 25 | K251466510(k) | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | Cardiovascular | JOW |
| Oct 28, 25 | K252165510(k) | ZIRCONOMER P | Shofu Dental Corporation | Dental | EMA |
| Oct 28, 25 | K252351510(k) | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | Orthopedic | MAX |
| Oct 28, 25 | K252376510(k) | Yomi S Robotic System | Neocis, Inc. | Dental | PLV |
| Oct 28, 25 | K252547510(k) | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | Radiology | LLZ |
| Oct 28, 25 | K252742510(k) | Navigated Instruments | Tyber Medical, LLC | Neurology | OLO |
| Oct 28, 25 | K253300510(k) | Fine Osteotomy | Bodycad Laboratories, Inc. | Orthopedic | HRS |
| Oct 28, 25 | K253399510(k) | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device | Cardiovascular | OBJ |
| Oct 27, 25 | K250297510(k) | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | Neurology | GWO |
| Oct 27, 25 | K250520510(k) | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | Neurology | OLO |
| Oct 27, 25 | K251027510(k) | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | Radiology | QIH |
| Oct 27, 25 | K251331510(k) | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | Cardiovascular | DXN |
| Oct 27, 25 | K251824510(k) | Patriot Duo | Patriot Laser, LLC | General, Plastic Surgery | GEX |
| Oct 27, 25 | K251875510(k) | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Microbiology | SAN |
| Oct 27, 25 | K252053510(k) | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | General, Plastic Surgery | OHS |
| Oct 27, 25 | K252467510(k) | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | General Hospital | LYZ |
| Oct 27, 25 | K252629510(k) | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 27, 25 | K252630510(k) | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 24, 25 | K250345510(k) | Medline Bag Decanter | Medline Industries, LP | General Hospital | LHI |
| Oct 24, 25 | K250687510(k) | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | Dental | MUH |
| Oct 24, 25 | K250696510(k) | AccuCheck | Manteia Technologies Co., Ltd. | Radiology | IYE |
| Oct 24, 25 | K250904510(k) | Atalante X | Wandercraft SAS | Physical Medicine | PHL |
| Oct 24, 25 | K251059510(k) | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | Radiology | QIH |
| Oct 24, 25 | K251312510(k) | Vesalio Peripheral System | Vesalio, Inc. | Cardiovascular | QEZ |
| Oct 24, 25 | K251372510(k) | VersaD Delivery Catheter | Unity Medical, Inc. | Cardiovascular | QJP |
| Oct 24, 25 | K251710510(k) | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | Radiology | IZL |
| Oct 24, 25 | K251784510(k) | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | Dental | LRK |
| Oct 24, 25 | K251827510(k) | Azurion R3.1 | Philips Medical Systems B.V. | Radiology | OWB |
| Oct 24, 25 | K251974510(k) | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | Cardiovascular | DWJ |
| Oct 24, 25 | K252044510(k) | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | MBH |
| Oct 24, 25 | K252238510(k) | CoroFlow Cardiovascular System | Coroventis Research AB | Cardiovascular | DQK |
| Oct 24, 25 | K252357510(k) | Glucose2 | Abbott Ireland | Clinical Chemistry | CFR |
| Oct 24, 25 | K252645510(k) | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Cardiovascular | DQK |
| Oct 24, 25 | K252646510(k) | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | Gastroenterology, Urology | FCG |
| Oct 24, 25 | K252730510(k) | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | NKB |
| Oct 24, 25 | K253106510(k) | AngioVac Cannula | AngioDynamics, Inc. | Cardiovascular | DWF |
| Oct 24, 25 | K253125510(k) | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | General, Plastic Surgery | FTL |
| Oct 24, 25 | K253129510(k) | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKG |
| Oct 24, 25 | K253150510(k) | Cryon-X Cold Compression | Jkh Health Co., Ltd. | Physical Medicine | IRP |
| Oct 24, 25 | K253188510(k) | CoaguChek XS Plus System | Roche Diagnostics | Hematology | GJS |
| Oct 24, 25 | K253335510(k) | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKB |
| Oct 24, 25 | K253377510(k) | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Orthopedic | MAX |
| Oct 23, 25 | K250288510(k) | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | Radiology | QIH |
| Oct 23, 25 | K250861510(k) | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | General Hospital | LZA |
| Oct 23, 25 | K252309510(k) | PerQseal Introducers | Vivasure Medical Limited | Cardiovascular | DYB |
| Oct 23, 25 | K252345510(k) | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 23, 25 | K252384510(k) | DESS® Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Oct 23, 25 | K252425510(k) | Silatrix Oral Gel | Sa3, LLC | Unknown | OLR |
| Oct 23, 25 | K252732510(k) | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 23, 25 | K252931510(k) | Invisalign® Palatal Expander System | Align Technology, Inc. | Dental | NXC |
| Oct 23, 25 | K253100510(k) | MultiPulse TFL | Asclepion Laser Technologies GmbH | General, Plastic Surgery | GEX |
| Oct 23, 25 | K253226510(k) | UV5000W Handle | Uroviu Corporation | Gastroenterology, Urology | FAJ |
| Oct 22, 25 | K250666510(k) | Alegria Flash CTD Screen | Zeus Scientific | Immunology | LLL |
| Oct 22, 25 | K250955510(k) | XC11 ICE System, USA | Yorlabs, Inc. | Cardiovascular | OBJ |
| Oct 22, 25 | K251030510(k) | Sirona Advanced Imaging Suite | Sirona Medical | Radiology | LLZ |
| Oct 22, 25 | K251185510(k) | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | Cardiovascular | QEW |
| Oct 22, 25 | K251289510(k) | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | Microbiology | QVF |
| Oct 22, 25 | K251628510(k) | Mandibular Advancement Device L07 | Dcstar, Inc. | Dental | LRK |
| Oct 22, 25 | K251663510(k) | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | General Hospital | FMZ |
| Oct 22, 25 | K251749510(k) | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | Microbiology | SCA |
| Oct 22, 25 | K251977510(k) | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 22, 25 | K252298510(k) | ANDI 2.0 | Imeka Solutions, Inc. | Radiology | QIH |
| Oct 22, 25 | K252322510(k) | SIros-X System | Genesys Spine | Orthopedic | OUR |
| Oct 22, 25 | K252325510(k) | Hair Growth Laser Cap | Cosmo Far East Technology Limited | Physical Medicine | OAP |
| Oct 22, 25 | K252329510(k) | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Microbiology | PCH |
| Oct 22, 25 | K252569510(k) | Carrier XL Delivery Catheter | Balt USA, LLC | Cardiovascular | QJP |
| Oct 22, 25 | K253144510(k) | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Oct 22, 25 | K253145510(k) | Pre-Sutured Tendon | Rti Surgical, Inc. | General, Plastic Surgery | GAT |
| Oct 22, 25 | K253147510(k) | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | Orthopedic | MQV |
| Oct 21, 25 | K231897510(k) | NeuroAlign software | Medivis, Inc. | Neurology | HAW |
| Oct 21, 25 | K250126510(k) | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | General, Plastic Surgery | GEI |
| Oct 21, 25 | K250394510(k) | Fine TTO | Bodycad Laboratories, Inc. | Orthopedic | PBF |
| Oct 21, 25 | K250409510(k) | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | Gastroenterology, Urology | FGE |
| Oct 21, 25 | K250887510(k) | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Anesthesiology | KOI |
| Oct 21, 25 | K251838510(k) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Cardiovascular | DYB |
| Oct 21, 25 | K252346510(k) | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | Orthopedic | NKB |
| Oct 21, 25 | K253033510(k) | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | General Hospital | ONB |
| Oct 21, 25 | K253034510(k) | HemoSphere Stream Module | Edwards Lifesciences | Cardiovascular | DQK |
| Oct 21, 25 | K253040510(k) | Aevumed FASE Suture Anchor | Aevumed, Inc. | Orthopedic | MBI |
| Oct 21, 25 | K253249510(k) | TriALTIS Spine System | Medos International SARL | Orthopedic | NKB |
| Oct 20, 25 | K242827510(k) | A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. | Orthopedic | NKB |
| Oct 20, 25 | K251414510(k) | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | General, Plastic Surgery | NEW |
| Oct 20, 25 | K252155510(k) | AVAVA Skin Treatment System | AVAVA, Inc. | General, Plastic Surgery | ONG |
| Oct 20, 25 | K252277510(k) | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | Cardiovascular | DSY |
| Oct 20, 25 | K252319510(k) | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 20, 25 | K252640510(k) | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | Gastroenterology, Urology | GCJ |
| Oct 20, 25 | K252665510(k) | brAIn Shoulder Positioning | Avatar Medical | Radiology | QIH |
| Oct 20, 25 | K253182510(k) | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | Radiology | MOS |
| Oct 17, 25 | DEN240076510(k) | Modius Lean | Neurovalens Limited | Gastroenterology, Urology | SFW |
| Oct 17, 25 | K250145510(k) | Biopsy Port Adapter | Endosound, Inc. | Gastroenterology, Urology | ODC |
| Oct 17, 25 | K250159510(k) | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | Immunology | SGG |
| Oct 17, 25 | K250178510(k) | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | Dental | NHA |
| Oct 17, 25 | K250197510(k) | Estremo Fibular Nail | Citieffe S.R.L. | Orthopedic | HSB |
| Oct 17, 25 | K250203510(k) | SureAx-Guide | Sureax Medical, LLC | Cardiovascular | DQX |
| Oct 17, 25 | K250227510(k) | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | Neurology | NFO |
| Oct 17, 25 | K250250510(k) | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | Immunology | JZO |
| Oct 17, 25 | K250911510(k) | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | Radiology | IYE |
| Oct 17, 25 | K250945510(k) | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | Gastroenterology, Urology | KNS |
| Oct 17, 25 | K251146510(k) | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | Cardiovascular | MHX |
| Oct 17, 25 | K251282510(k) | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | Neurology | OLO |
| Oct 17, 25 | K251355510(k) | X1-FFR | Spectrawave, Inc. | Radiology | QHA |
| Oct 17, 25 | K251673510(k) | X9 Ultrasound System | X9, Inc. | Radiology | SGH |
| Oct 17, 25 | K251778510(k) | Remi Custom Night Guard | Remi | Unknown | OBR |
| Oct 17, 25 | K251832510(k) | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | Neurology | HCG |
| Oct 17, 25 | K252075510(k) | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | General Hospital | LZA |
| Oct 17, 25 | K252254510(k) | Osteotomy Wedge System | Sinaptic Surgical | Orthopedic | PLF |
| Oct 17, 25 | K252264510(k) | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Oct 17, 25 | K252266510(k) | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Dental | NHA |
| Oct 16, 25 | K242100510(k) | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | Unknown | KGN |
| Oct 16, 25 | K243727510(k) | Re:Balans | Mode Sensors AS | Cardiovascular | DSB |
| Oct 16, 25 | K250731510(k) | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | General, Plastic Surgery | NVK |
| Oct 16, 25 | K250852510(k) | Coolfase | Asterasys Co., Ltd. | General, Plastic Surgery | GEI |
| Oct 16, 25 | K251497510(k) | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | Dental | NHA |
| Oct 16, 25 | K251882510(k) | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | Obstetrics/Gynecology | HHK |
| Oct 16, 25 | K251994510(k) | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | Gastroenterology, Urology | GCJ |
| Oct 16, 25 | K252024510(k) | NeurAxis IB-Stim (01-1020) | Neuraxis | Gastroenterology, Urology | QHH |
| Oct 16, 25 | K252093510(k) | Light Therapy Mask (1019055) | Merchsource, LLC | General, Plastic Surgery | OHS |
| Oct 16, 25 | K252153510(k) | FFX Facet Fixation System | Sc Medica | Unknown | MRW |
| Oct 16, 25 | K252223510(k) | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Dental | EKX |
| Oct 16, 25 | K252247510(k) | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corporation | Gastroenterology, Urology | FBK |
| Oct 16, 25 | K252476510(k) | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | Radiology | LLZ |
| Oct 16, 25 | K252612510(k) | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | Cardiovascular | QEW |
| Oct 16, 25 | K252631510(k) | Profoject Disposable Needle | CMT Health PTE., Ltd. | General Hospital | FMI |
| Oct 16, 25 | K253000510(k) | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | General, Plastic Surgery | GEH |
| Oct 16, 25 | K253024510(k) | ProZip Knotless Implant | Riverpoint Medical | General, Plastic Surgery | GAT |
| Oct 16, 25 | K253114510(k) | TargetCool (RM-DT02W) | Recensmedical, Inc. | General, Plastic Surgery | GEH |
| Oct 15, 25 | K250107510(k) | V-soft Line Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | General, Plastic Surgery | NEW |
| Oct 15, 25 | K250510510(k) | Sure-Fine Insulin Syringes | Shina Med Corporation | General Hospital | FMF |
| Oct 15, 25 | K250979510(k) | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Zoll Circulation, Inc. | Cardiovascular | NZE |
| Oct 15, 25 | K251294510(k) | Bonafix Implant Abutments | Zentek Medical, LLC | Dental | NHA |
| Oct 15, 25 | K251805510(k) | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| Oct 15, 25 | K252020510(k) | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Orthopedic | HRX |
| Oct 15, 25 | K252199510(k) | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | Radiology | LLZ |
| Oct 15, 25 | K252367510(k) | InbellaMulti System | Inbella Medical, Inc. | General, Plastic Surgery | GEI |
| Oct 15, 25 | K252920510(k) | ELEOS Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | Orthopedic | QZZ |
| Oct 15, 25 | K252944510(k) | LOCATOR® Angled Abutment | Zest Anchors, LLC | Dental | NHA |
| Oct 15, 25 | K252946510(k) | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | Orthopedic | MAI |
| Oct 15, 25 | K253348510(k) | TargetCool-e | Recensmedical, Inc. | General, Plastic Surgery | GEH |
| Oct 14, 25 | K250115510(k) | Hemastyl() Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | Unknown | FRO |
| Oct 14, 25 | K250776510(k) | Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC | General, Plastic Surgery | GEX |
| Oct 14, 25 | K251715510(k) | FlowArt® Vial Access Device Vented | Asset Medikal | General Hospital | LHI |
| Oct 14, 25 | K251874510(k) | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | General Hospital | MMK |
| Oct 14, 25 | K252234510(k) | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) | Shenzhen Qiaochengli Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Oct 14, 25 | K252637510(k) | Community Containers (Flap and Daisy) | Keter Canada, Inc. | General Hospital | MMK |
| Oct 14, 25 | K253010510(k) | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | Orthopedic | MBI |
| Oct 14, 25 | K253099510(k) | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | Cardiovascular | MPD |
| Oct 14, 25 | K253331510(k) | PressON Spinal Fixation System | Nexus Spine | Orthopedic | NKB |
| Oct 14, 25 | K253461510(k) | Demi Pro | Meta Systems Co., Ltd. | Dental | EBZ |
| Oct 13, 25 | K251522510(k) | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. | Orthopedic | MQV |
| Oct 12, 25 | K242227510(k) | GENEO X ELITE | Pollogen, Ltd. | General, Plastic Surgery | PAY |
| Oct 12, 25 | K251034510(k) | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | Neurology | NFO |
| Oct 12, 25 | K251595510(k) | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | Microbiology | QYT |
| Oct 10, 25 | K243078510(k) | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | Dental | DZE |
| Oct 10, 25 | K243815510(k) | SoClean 3+ | Soclean, Inc. | General Hospital | QXQ |
| Oct 10, 25 | K250085510(k) | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | Clinical Chemistry | NBW |
| Oct 10, 25 | K250249510(k) | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | Microbiology | GMQ |
| Oct 10, 25 | K250351510(k) | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | Gastroenterology, Urology | KNS |
| Oct 10, 25 | K251082510(k) | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics | General, Plastic Surgery | PZP |
| Oct 10, 25 | K251602510(k) | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | Radiology | OWB |
| Oct 10, 25 | K251708510(k) | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Gastroenterology, Urology | FDS |
| Oct 10, 25 | K251835510(k) | Yomi Robotic System | Neocis, Inc. | Dental | PLV |
| Oct 10, 25 | K251866510(k) | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | Unknown | FRO |
| Oct 10, 25 | K251927510(k) | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Neurology | SGE |
| Oct 10, 25 | K252001510(k) | Collagen Wound Dressing | Winner Medical Co., Ltd. | Unknown | KGN |
| Oct 10, 25 | K252209510(k) | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. | General, Plastic Surgery | OHT |
| Oct 10, 25 | K252312510(k) | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | Orthopedic | HWC |
| Oct 10, 25 | K252544510(k) | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
| Oct 10, 25 | K252737510(k) | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | Orthopedic | ODP |
| Oct 10, 25 | K252903510(k) | Verruca-Freeze H Plus | Cryosurgery, Inc. | General, Plastic Surgery | GEH |
| Oct 9, 25 | K250645510(k) | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. | Gastroenterology, Urology | FER |
| Oct 9, 25 | K251366510(k) | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation | Neurology | OLT |
| Oct 9, 25 | K251651510(k) | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Oct 9, 25 | K251795510(k) | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | Cardiovascular | DXN |
| Oct 9, 25 | K251851510(k) | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | FIP |
| Oct 9, 25 | K251876510(k) | cleadew GP hydra one | Ophtecs Corporation | Ophthalmic | MRC |
| Oct 9, 25 | K252272510(k) | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OHS |
| Oct 9, 25 | K252553510(k) | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Neurology | NFO |
| Oct 9, 25 | K252600510(k) | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | Orthopedic | HRS |
| Oct 9, 25 | K252867510(k) | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | Clinical Toxicology | NFT |
| Oct 9, 25 | K252870510(k) | Invisalign Specifix Attachment System | Align Technology, Inc. | Dental | NXC |
| Oct 9, 25 | K252910510(k) | Orca Air/Water and Suction Valves | Boston Scientific | Gastroenterology, Urology | ODC |
| Oct 9, 25 | K252911510(k) | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | Radiology | MQB |
| Oct 9, 25 | K252939510(k) | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | Obstetrics/Gynecology | HEB |
| Oct 9, 25 | K253094510(k) | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | Orthopedic | OUR |
| Oct 8, 25 | K250060510(k) | GT300; GT300-C | Genoray Co., Ltd. | Radiology | OAS |
| Oct 8, 25 | K250298510(k) | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | Clinical Innovations, LLC | Obstetrics/Gynecology | HDB |
| Oct 8, 25 | K250536510(k) | MetaFore Small Screw System | Extremity Medical, LLC | Orthopedic | HWC |
| Oct 8, 25 | K251162510(k) | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | Unknown | LFL |
| Oct 8, 25 | K251363510(k) | ProKnow DS | Elekta Solutions AB | Radiology | LLZ |
| Oct 8, 25 | K251422510(k) | BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | General Hospital | FOZ |
| Oct 8, 25 | K251699510(k) | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | General, Plastic Surgery | GEX |
| Oct 8, 25 | K252163510(k) | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | Immunology | SET |
| Oct 8, 25 | K252766510(k) | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | Cardiovascular | DYB |
| Oct 8, 25 | K252874510(k) | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | Ear, Nose, Throat | KTI |
| Oct 7, 25 | K244041510(k) | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | Physical Medicine | IMG |
| Oct 7, 25 | K250187510(k) | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | Gastroenterology, Urology | KGE |
| Oct 7, 25 | K250364510(k) | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | Ophthalmic | LPL |
| Oct 7, 25 | K250688510(k) | Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) | Acotec Scientific Co., Ltd. | General, Plastic Surgery | GEI |
| Oct 7, 25 | K250894510(k) | Eminent Spine Posterior SI System | Eminent Spine | Orthopedic | OUR |
| Oct 7, 25 | K252150510(k) | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corporation | General, Plastic Surgery | GEI |
| Oct 7, 25 | K252214510(k) | AIAS Cephalon | Metamorphosis GmbH | Radiology | QIH |
| Oct 7, 25 | K252572510(k) | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | Gastroenterology, Urology | FED |
| Oct 7, 25 | K252851510(k) | deepLive (OSP12 + DMS) | Damae Medical | Radiology | NQQ |
| Oct 7, 25 | K252948510(k) | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | Radiology | IYE |
| Oct 6, 25 | DEN240073510(k) | PainChek (PainChek Adult) | Painchek Limited (Ltd.) | Neurology | SGB |
| Oct 6, 25 | K250173510(k) | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | Covidien, LLC | Anesthesiology | BTR |
| Oct 6, 25 | K251565510(k) | Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | Physical Medicine | ITI |
| Oct 6, 25 | K251603510(k) | Tigertriever 17 Ultra Revascularization Device | Rapid Medical Ltd. | Cardiovascular | NRY |
| Oct 6, 25 | K252007510(k) | BlineSlide | Deep Breathe, Inc. | Radiology | QIH |
| Oct 6, 25 | K252140510(k) | Heylo System | Coloplast Corp. | Gastroenterology, Urology | EXB |
| Oct 6, 25 | K252502510(k) | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | Physical Medicine | INI |
| Oct 3, 25 | DEN220077510(k) | ProSense System | Icecure Medical | General, Plastic Surgery | QXW |
| Oct 3, 25 | K242946510(k) | HESTIA (L200-A) | Senbitec Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 3, 25 | K243968510(k) | Revolve Surgical System | Revolve Surgical, Inc. | Gastroenterology, Urology | GCJ |
| Oct 3, 25 | K250028510(k) | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | Dental | LRK |
| Oct 3, 25 | K250031510(k) | Amplatzer Guidewire | ABBOTT MEDICAL | Cardiovascular | DQX |
| Oct 3, 25 | K250039510(k) | HPACS | Healthhub | Radiology | LLZ |
| Oct 3, 25 | K250073510(k) | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | Clinical Chemistry | PDJ |
| Oct 3, 25 | K250662510(k) | Bunkerhill MAC | BunkerHill Health | Radiology | JAK |
| Oct 3, 25 | K251426510(k) | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Oct 3, 25 | K251464510(k) | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated | General, Plastic Surgery | GEX |
| Oct 3, 25 | K251468510(k) | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Hollister Incorporated | Gastroenterology, Urology | EZD |
| Oct 3, 25 | K251639510(k) | xvision Spine system | Augmedics, Ltd. | Neurology | SBF |
| Oct 3, 25 | K251646510(k) | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | General, Plastic Surgery | OMP |
| Oct 3, 25 | K251859510(k) | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Gastroenterology, Urology | ODG |
| Oct 3, 25 | K252129510(k) | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | Orthopedic | PKC |
| Oct 3, 25 | K252178510(k) | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | Gastroenterology, Urology | QNP |
| Oct 3, 25 | K252517510(k) | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | Physical Medicine | IOR |
| Oct 3, 25 | K252806510(k) | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. | Gastroenterology, Urology | FGB |
| Oct 3, 25 | K252820510(k) | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V | General, Plastic Surgery | GAM |
| Oct 2, 25 | K243152510(k) | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | Obstetrics/Gynecology | HEW |
| Oct 2, 25 | K250523510(k) | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC | Gastroenterology, Urology | FKX |
| Oct 2, 25 | K250551510(k) | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | Gastroenterology, Urology | GCJ |
| Oct 2, 25 | K250766510(k) | LungQ 4 | Thirona BV | Radiology | JAK |
| Oct 2, 25 | K250860510(k) | BreatheBand® (Model 1000) | Exemplar Medical, LLC | Anesthesiology | BYI |
| Oct 2, 25 | K251124510(k) | G-Bond Universal | GC America, Inc. | Dental | KLE |
| Oct 2, 25 | K251215510(k) | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | Radiology | LLZ |
| Oct 2, 25 | K251398510(k) | IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Oct 2, 25 | K251442510(k) | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | Gastroenterology, Urology | FJK |
| Oct 2, 25 | K252059510(k) | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | Unknown | OHA |
| Oct 2, 25 | K252114510(k) | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | Microbiology | JWY |
| Oct 2, 25 | K252440510(k) | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | Cardiovascular | DRG |
| Oct 2, 25 | K252758510(k) | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | Orthopedic | HWC |
| Oct 2, 25 | K252769510(k) | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | Cardiovascular | DXN |
| Oct 1, 25 | K250026510(k) | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Wuxi Hisky Medical Technologies Co., Ltd. | Radiology | IYN |
| Oct 1, 25 | K250083510(k) | PRO-DOSE System | Nu-Rise, SA | Radiology | NZT |
| Oct 1, 25 | K250767510(k) | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | Orthopedic | PBF |
| Oct 1, 25 | K251501510(k) | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | Microbiology | QEP |
| Oct 1, 25 | K251767510(k) | Vena MicroAngioscope System | Vena Medical Holdings Corp | Gastroenterology, Urology | LYK |
| Oct 1, 25 | K251825510(k) | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. | General, Plastic Surgery | OHS |
| Oct 1, 25 | K251899510(k) | E Blator | New Deantronics Taiwan , Ltd. | General, Plastic Surgery | GEI |
| Oct 1, 25 | K252096510(k) | Light Therapy Decollete Mask (1019135) | Merchsource, LLC | General, Plastic Surgery | OHS |
| Oct 1, 25 | K252447510(k) | Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 1, 25 | K252804510(k) | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. | General, Plastic Surgery | OHT |
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
September 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.