The Tracker // September 2026
September 2026: 323 FDA device decisions
319 510(k) clearances and 4 original PMA approvals with a decision date in September 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Sep 30, 26 | K254302510(k) | ECG Analysis Software (AiTiALVSD) | Medical AI Co., Ltd. | Cardiovascular | QYE |
| Sep 30, 26 | K261327510(k) | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | Dental | NHA |
| Sep 30, 26 | K261469510(k) | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). | Barco N.V. | Cardiovascular | DXJ |
| Sep 30, 26 | K261663510(k) | EzSensor HD | Qpix Solutions, Inc. | Dental | MUH |
| Sep 30, 26 | K261975510(k) | Braun Aura 7 (6041) | CyDen Limited | General, Plastic Surgery | OHT |
| Sep 30, 26 | K262038510(k) | danumed StomaMeter | Danumed Medizintechnik GmbH | Gastroenterology, Urology | KNT |
| Sep 30, 26 | K262257510(k) | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | Neurology | OLO |
| Sep 30, 26 | K262621510(k) | Rapid Barostat Bag (RBB) Pump and Catheter System | Mui Scientific, Inc. | Gastroenterology, Urology | FFX |
| Sep 30, 26 | K262712510(k) | Duet Spinal Fixation System | Duet Spine Holdings, LLC | Orthopedic | NKB |
| Sep 30, 26 | K262893510(k) | Eonis SMA kit | Revvity, Inc. | Immunology | QUE |
| Sep 30, 26 | K263033510(k) | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd. | Radiology | OAS |
| Sep 30, 26 | K263035510(k) | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) | Centers for Disease Control and Prevention | Microbiology | OZE |
| Sep 30, 26 | K263172510(k) | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | Orthopedic | NKB |
| Sep 29, 26 | DEN260007510(k) | SmartRead(TM) Medical Device Identifier (4100) | BridgeSource Medical Corporation | Cardiovascular | SJJ |
| Sep 29, 26 | K260031510(k) | THERMEO® I MSI | Pro3Dure Medical GmbH | Unknown | MQC |
| Sep 29, 26 | K260250510(k) | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | Cardiovascular | DPS |
| Sep 29, 26 | K261225510(k) | CAS-One IR | Cascination AG | Radiology | JAK |
| Sep 29, 26 | K262015510(k) | Elucid FFR-IQ (B.1) | Elucid Bioimaging, Inc. | Cardiovascular | PJA |
| Sep 29, 26 | K262213510(k) | Power Mobility Scooter (MA03) | Nanjing Mijo Technology Co., Ltd. | Physical Medicine | INI |
| Sep 29, 26 | K262241510(k) | Electric Wheelchair (0080) | Xuzhou Heabens Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Sep 29, 26 | K262553510(k) | MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) | Zhejiang Kailang Technology Co., Ltd. | Physical Medicine | INI |
| Sep 29, 26 | K262721510(k) | Spinalogic Bone Growth Stimulator | Djo, LLC | Orthopedic | LOF |
| Sep 29, 26 | K262726510(k) | NeckTune SA Cervical Cage | Medyssey Co., Ltd. | Orthopedic | OVE |
| Sep 29, 26 | K263048510(k) | Syngo Carbon Space (VA4) | Siemens Healthineers AG | Radiology | LLZ |
| Sep 29, 26 | K263073510(k) | Fast Absorbing PGLA | Riverpoint Medical, LLC | General, Plastic Surgery | GAM |
| Sep 28, 26 | K260474510(k) | Liora Monofilament Scaffold | TELA Bio, Inc. | General, Plastic Surgery | FTL |
| Sep 28, 26 | K260619510(k) | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) | Biomérieux, Inc. | Microbiology | LON |
| Sep 28, 26 | K261543510(k) | Phasix ST Parastomal Hernia Mesh | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | General, Plastic Surgery | OWT |
| Sep 28, 26 | K262052510(k) | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | Cardiovascular | DWF |
| Sep 28, 26 | K262649510(k) | Alians Forearm | Newclip Technics | Orthopedic | HRS |
| Sep 28, 26 | P250051PMA | Juveena Hydrogel System | Rejoni, Inc. | Obstetrics/Gynecology | MCN |
| Sep 27, 26 | K252139510(k) | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | Orthopedic | NKB |
| Sep 27, 26 | K260945510(k) | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | Fit-Pro KFT (Ltd.) - DBA E-Fit | Unknown | |
| Sep 25, 26 | K254058510(k) | DistaSense(TM) (v1) | Life Detection Technologies | Cardiovascular | DRT |
| Sep 25, 26 | K254210510(k) | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | Dental | NPM |
| Sep 25, 26 | K254230510(k) | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | Gastroenterology, Urology | QZF |
| Sep 25, 26 | K254252510(k) | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | Obstetrics/Gynecology | HIH |
| Sep 25, 26 | K254255510(k) | S-Patch CardioAI | Wellysis Corp. | Cardiovascular | DPS |
| Sep 25, 26 | K254291510(k) | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | General, Plastic Surgery | GDW |
| Sep 25, 26 | K254297510(k) | Tempus ECG-MR | Tempus AI, Inc. | Cardiovascular | SBQ |
| Sep 25, 26 | K260023510(k) | TumorSight Risk | SimBioSys, Inc. | Pathology | SHW |
| Sep 25, 26 | K260055510(k) | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| Sep 25, 26 | K260140510(k) | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | Anesthesiology | PHZ |
| Sep 25, 26 | K261262510(k) | Altis Full Face Mask | Respironics, Inc. | Anesthesiology | BZD |
| Sep 25, 26 | K261336510(k) | Xpert Respiratory Panel | Cepheid | Microbiology | QOF |
| Sep 25, 26 | K261372510(k) | Profoject LOR Syringe | CMT Health PTE., Ltd. | Anesthesiology | CAZ |
| Sep 25, 26 | K261977510(k) | Braun Aura 9 (6042) | Cyden Limited | General, Plastic Surgery | OHT |
| Sep 25, 26 | K261992510(k) | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | General Hospital | JOJ |
| Sep 25, 26 | K262196510(k) | Invisalign System | Align Technology, Inc. | Dental | PNN |
| Sep 25, 26 | K262215510(k) | Profoject Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | Clinical Chemistry | JKA |
| Sep 25, 26 | K262548510(k) | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Sep 25, 26 | K262975510(k) | Arthrex Beaming System | Arthrex, Inc. | Orthopedic | HWC |
| Sep 25, 26 | K262983510(k) | EsTemp Implant | Spident Co., Ltd. | Dental | EMA |
| Sep 25, 26 | K263182510(k) | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| Sep 25, 26 | P250050PMA | Liverty TIPS Stent Graft | Bard Peripheral Vascular, Inc. | Cardiovascular | MIR |
| Sep 24, 26 | K254199510(k) | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 24, 26 | K254303510(k) | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | Obstetrics/Gynecology | KNF |
| Sep 24, 26 | K260114510(k) | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | Radiology | ITX |
| Sep 24, 26 | K260214510(k) | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | Hematology | KFF |
| Sep 24, 26 | K260313510(k) | MD-6000S Bladder Scanner | MEDA Co., Ltd. | Radiology | IYO |
| Sep 24, 26 | K260949510(k) | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | Anesthesiology | MNR |
| Sep 24, 26 | K261078510(k) | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | Physical Medicine | INI |
| Sep 24, 26 | K261345510(k) | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | Orthopedic | HSB |
| Sep 24, 26 | K262149510(k) | corra® cervical plating system | Carlsmed, Inc. | Orthopedic | KWQ |
| Sep 24, 26 | K262168510(k) | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | Microbiology | PEN |
| Sep 24, 26 | K262183510(k) | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | Physical Medicine | OAP |
| Sep 24, 26 | K262252510(k) | MPa Max adhesive | Den-Mat Holdings, LLC | Dental | KLE |
| Sep 24, 26 | K262618510(k) | Arthrex Spine Compression FT Screw | Arthrex, Inc. | Unknown | MRW |
| Sep 24, 26 | K262955510(k) | OsseoFit Stemless Shoulder System | Zimmer, Inc. | Orthopedic | PKC |
| Sep 24, 26 | K263010510(k) | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | Neurology | GWF |
| Sep 23, 26 | K254289510(k) | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | Anesthesiology | CAW |
| Sep 23, 26 | K260117510(k) | Everslide | Special Situations, LLC | Obstetrics/Gynecology | NUC |
| Sep 23, 26 | K260597510(k) | VIRTUE QA | ProNova Solutions | Radiology | LHN |
| Sep 23, 26 | K260995510(k) | DynaNail Helix® Fixation System | MedShape, Inc. | Orthopedic | HWC |
| Sep 23, 26 | K261418510(k) | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | Gastroenterology, Urology | EZD |
| Sep 23, 26 | K261453510(k) | G7® Acetabular System | Zimmer Biomet | Orthopedic | LPH |
| Sep 23, 26 | K261637510(k) | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | Ear, Nose, Throat | EOQ |
| Sep 23, 26 | K261874510(k) | Syneris PACS v.1.0.1.0 | Syneris | Radiology | LLZ |
| Sep 23, 26 | K261892510(k) | ProRib Fixation System | Costa Surgical, Inc. | Orthopedic | HRS |
| Sep 23, 26 | K262067510(k) | iFuse Granite Onyx Implant System | SI-BONE, Inc. | Orthopedic | NKB |
| Sep 23, 26 | K262144510(k) | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | Dental | EFB |
| Sep 23, 26 | K262156510(k) | Anti-HCV Next | Abbott Laboratories | Microbiology | MZO |
| Sep 23, 26 | K262207510(k) | Cemented Plus Abutment | Unidental Co., Ltd. | Dental | NHA |
| Sep 23, 26 | K262254510(k) | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | Physical Medicine | OAP |
| Sep 23, 26 | K262353510(k) | BTL-299-F | BTL Industries, Inc. | Gastroenterology, Urology | KPI |
| Sep 23, 26 | K262582510(k) | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | Physical Medicine | ITI |
| Sep 23, 26 | K263049510(k) | SABER-C System | Elevation Spine | Orthopedic | OVE |
| Sep 22, 26 | K243223510(k) | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | General, Plastic Surgery | PBX |
| Sep 22, 26 | K253762510(k) | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | Physical Medicine | IOR |
| Sep 22, 26 | K254168510(k) | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | Unknown | FRO |
| Sep 22, 26 | K254240510(k) | Echo-2 | Neko Health AB | Cardiovascular | QOK |
| Sep 22, 26 | K261125510(k) | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | Radiology | JAK |
| Sep 22, 26 | K262299510(k) | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | Clinical Chemistry | JHI |
| Sep 22, 26 | K262390510(k) | BoneXpert | Visiana | Radiology | QIH |
| Sep 22, 26 | K262442510(k) | HipStudio Analysis | Replasia BV | Radiology | LLZ |
| Sep 22, 26 | K263054510(k) | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | Microbiology | QOF |
| Sep 21, 26 | K253509510(k) | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | Cardiovascular | KRA |
| Sep 21, 26 | K254280510(k) | F.A.S.T Screw | Steps Ortho | Orthopedic | HWC |
| Sep 21, 26 | K260416510(k) | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | Cardiovascular | LIT |
| Sep 21, 26 | K260512510(k) | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Gastroenterology, Urology | FED |
| Sep 21, 26 | K260940510(k) | BellaTek Bars | ZimVie US Corp, LLC | Dental | NHA |
| Sep 21, 26 | K261368510(k) | Rapid Platform (R6.7) | Ischemaview, Inc. | Radiology | QIH |
| Sep 21, 26 | K261725510(k) | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | Ear, Nose, Throat | SHL |
| Sep 21, 26 | K262108510(k) | FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO | Shanghai Personage Hygiene Products Co., Ltd. | Obstetrics/Gynecology | HIS |
| Sep 21, 26 | K262109510(k) | Access NT-proBNP | Beckman Coulter, Inc. | Clinical Chemistry | NBC |
| Sep 21, 26 | K262547510(k) | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | Gastroenterology, Urology | OWN |
| Sep 21, 26 | K262982510(k) | Core·it Dual | Spident Co., Ltd. | Dental | EBF |
| Sep 19, 26 | K241973510(k) | SmartIPL_NI System | Lumenis Be, Ltd. | General, Plastic Surgery | GEX |
| Sep 19, 26 | K252723510(k) | Dynamis Pro Family | Fotona D.O.O. | General, Plastic Surgery | GEX |
| Sep 19, 26 | K261859510(k) | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | Physical Medicine | INI |
| Sep 18, 26 | K253146510(k) | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | Cardiovascular | DQX |
| Sep 18, 26 | K253419510(k) | Triever Duo Catheter | Inari Medical, Inc. | Cardiovascular | QEW |
| Sep 18, 26 | K254095510(k) | 25G Huber Needle | Martech Medical Products | General Hospital | PTI |
| Sep 18, 26 | K254160510(k) | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | General, Plastic Surgery | OKO |
| Sep 18, 26 | K254171510(k) | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | Anesthesiology | CAF |
| Sep 18, 26 | K254179510(k) | Drainage Catheter | Canyon Medical, Inc. | Gastroenterology, Urology | FGE |
| Sep 18, 26 | K254238510(k) | MINT MONO Sutures | Hans Biomed Corporation | General, Plastic Surgery | NEW |
| Sep 18, 26 | K260008510(k) | Deterioration Index Version 2 | Epic Systems Corporation | Cardiovascular | QNL |
| Sep 18, 26 | K261047510(k) | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 18, 26 | K261102510(k) | UNIDRIVE Select System | Karl Storz SE & CO. KG | Obstetrics/Gynecology | HIH |
| Sep 18, 26 | K261229510(k) | SCENARIA View Phase 6.0 | Fujifilm Corporation | Radiology | JAK |
| Sep 18, 26 | K261855510(k) | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | Radiology | LLZ |
| Sep 18, 26 | K262098510(k) | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | Orthopedic | HRS |
| Sep 18, 26 | K262262510(k) | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | Gastroenterology, Urology | FED |
| Sep 18, 26 | K262524510(k) | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Sep 18, 26 | K262532510(k) | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | General Hospital | LGZ |
| Sep 18, 26 | K262599510(k) | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | Clinical Chemistry | SFU |
| Sep 18, 26 | K262637510(k) | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | Ophthalmic | HJO |
| Sep 18, 26 | K262817510(k) | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | Cardiovascular | DQY |
| Sep 18, 26 | P250041PMA | SELUTION SLR 014 PTCA Drug-Eluting Balloon | MedAlliance, LLC | Cardiovascular | OOB |
| Sep 17, 26 | K252995510(k) | Durashield Device Kit | SurGenTec, LLC | Neurology | GZT |
| Sep 17, 26 | K254196510(k) | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | General, Plastic Surgery | GEI |
| Sep 17, 26 | K254203510(k) | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Sep 17, 26 | K254260510(k) | The VEGA Cervical Screw System | GS Medical Co., Ltd. | Orthopedic | NKG |
| Sep 17, 26 | K260173510(k) | M-Vizion Femoral Revision System Extension | Medacta International S.A. | Orthopedic | LZO |
| Sep 17, 26 | K260677510(k) | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | General, Plastic Surgery | FZP |
| Sep 17, 26 | K261266510(k) | MOWANA Auto Duo | PENTAMASTER MEDIQ SDN BHD | General Hospital | FMI |
| Sep 17, 26 | K261275510(k) | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | Orthopedic | MBH |
| Sep 17, 26 | K261392510(k) | TriActive Dental Implant System | Paragon Implant Mfg., LLC | Dental | DZE |
| Sep 17, 26 | K261673510(k) | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 17, 26 | K261729510(k) | EnSite X EP System | Abbott Medical | Cardiovascular | DQK |
| Sep 17, 26 | K261817510(k) | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 17, 26 | K261869510(k) | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | Orthopedic | MBI |
| Sep 17, 26 | K261959510(k) | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | General, Plastic Surgery | GEI |
| Sep 17, 26 | K262073510(k) | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | General, Plastic Surgery | PEM |
| Sep 17, 26 | K262091510(k) | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | Orthopedic | NKB |
| Sep 17, 26 | K262495510(k) | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | Ophthalmic | LPL |
| Sep 17, 26 | K262913510(k) | Protégé EverFlex Self-expanding Peripheral Stent System | Medtronic, Inc. | Gastroenterology, Urology | FGE |
| Sep 16, 26 | K254142510(k) | Dia-X Sil Heavy Body | DiaDent Group International | Dental | ELW |
| Sep 16, 26 | K254152510(k) | Dia-X Sil Light Body | DiaDent Group International | Dental | ELW |
| Sep 16, 26 | K254181510(k) | Aristotle 65 Macrowire | Scientia Vascular | Cardiovascular | MOF |
| Sep 16, 26 | K254212510(k) | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Cardiovascular | LIT |
| Sep 16, 26 | K260220510(k) | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | Cardiovascular | QJP |
| Sep 16, 26 | K260226510(k) | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | Anesthesiology | BZK |
| Sep 16, 26 | K260309510(k) | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | Ear, Nose, Throat | EOQ |
| Sep 16, 26 | K260906510(k) | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | Radiology | QAS |
| Sep 16, 26 | K261283510(k) | APERTO Lucent MRI System | Fujifilm Corporation | Radiology | LNH |
| Sep 16, 26 | K261370510(k) | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | Neurology | NFO |
| Sep 16, 26 | K261400510(k) | Ambu® aScope Gastro; Ambu® aScope Gastro Large | Ambu A/S | Gastroenterology, Urology | FDS |
| Sep 16, 26 | K261467510(k) | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | General, Plastic Surgery | SAH |
| Sep 16, 26 | K261623510(k) | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | QIH |
| Sep 16, 26 | K261712510(k) | Ceribell EEG Analysis Software | Ceribell, Inc. | Neurology | OLT |
| Sep 16, 26 | K261758510(k) | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | Radiology | LNH |
| Sep 16, 26 | K261778510(k) | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Cardiovascular | PNO |
| Sep 16, 26 | K261865510(k) | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | Radiology | IYE |
| Sep 16, 26 | K261888510(k) | ClearClub Impression Material | ClearClub | Dental | SHI |
| Sep 16, 26 | K261896510(k) | iOS CamAPS FX | CamDiab | Clinical Chemistry | QJI |
| Sep 16, 26 | K261913510(k) | X°Port Heart Preservation System | Traferox Technologies, Inc. | Gastroenterology, Urology | MSB |
| Sep 16, 26 | K261919510(k) | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Sep 16, 26 | K262054510(k) | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Sep 16, 26 | K262559510(k) | Mouth Guard | ChangSha ChuangDuoLe E-Commerce Co., Ltd. | Unknown | OBR |
| Sep 16, 26 | K262877510(k) | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | General, Plastic Surgery | GEX |
| Sep 15, 26 | K254214510(k) | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Radiology | LLZ |
| Sep 15, 26 | K254299510(k) | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | Ear, Nose, Throat | EOB |
| Sep 15, 26 | K260141510(k) | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Sep 15, 26 | K260144510(k) | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Sep 15, 26 | K260145510(k) | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Sep 15, 26 | K260446510(k) | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | Neurology | HAE |
| Sep 15, 26 | K261070510(k) | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | General, Plastic Surgery | GEI |
| Sep 15, 26 | K261447510(k) | CVAC® Aspiration System | Calyxo, Inc. | Gastroenterology, Urology | FGB |
| Sep 15, 26 | K261677510(k) | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | Radiology | QIH |
| Sep 15, 26 | K261861510(k) | SPINEsim v1.0 | Mdsim S.A. | Radiology | LLZ |
| Sep 15, 26 | K262057510(k) | GMK Extension | Medacta International SA | Orthopedic | JWH |
| Sep 15, 26 | K262963510(k) | TMC Implant Fixation System | Treace Medical Concepts, Inc. | Orthopedic | HRS |
| Sep 15, 26 | P250046PMA | OncoMate® MSI Dx Analysis System | Promega Corporation | Medical Genetics | SFL |
| Sep 14, 26 | K253481510(k) | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | Gastroenterology, Urology | PKL |
| Sep 14, 26 | K260781510(k) | Yumizen H550 | HORIBA ABX SAS | Hematology | GKZ |
| Sep 14, 26 | K260795510(k) | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | Dental | EHD |
| Sep 14, 26 | K261089510(k) | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | Cardiovascular | NRY |
| Sep 14, 26 | K261438510(k) | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | Cardiovascular | DTZ |
| Sep 14, 26 | K261517510(k) | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | Radiology | QDQ |
| Sep 14, 26 | K262163510(k) | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | Microbiology | JTZ |
| Sep 14, 26 | K262193510(k) | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | Orthopedic | NKB |
| Sep 13, 26 | K262526510(k) | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | FMK |
| Sep 12, 26 | K260133510(k) | CADDIE | Odin Medical Limited | Gastroenterology, Urology | QNP |
| Sep 12, 26 | K261287510(k) | Digistat Care | Ascom Ums Srl Unipersonale | Cardiovascular | MSX |
| Sep 11, 26 | K253063510(k) | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation | Anesthesiology | BTO |
| Sep 11, 26 | K254041510(k) | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | Unknown | FRO |
| Sep 11, 26 | K254051510(k) | Extroducer Infusion Catheter System | SmartWise Sweden AB | Cardiovascular | KRA |
| Sep 11, 26 | K254072510(k) | BoneVue | Curvebeam AI / Curvebeam, LLC | Radiology | KGI |
| Sep 11, 26 | K254119510(k) | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | Cardiovascular | MWJ |
| Sep 11, 26 | K254123510(k) | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | General Hospital | FPA |
| Sep 11, 26 | K254174510(k) | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | Neurology | HBC |
| Sep 11, 26 | K254177510(k) | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | Neurology | HBF |
| Sep 11, 26 | K254185510(k) | Potenza Prime | Jeisys Medical Incorporated | General, Plastic Surgery | GEI |
| Sep 11, 26 | K260001510(k) | Mint ACE Pump | Beta Bionics, Inc. | Clinical Chemistry | QFG |
| Sep 11, 26 | K260063510(k) | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | Orthopedic | JWH |
| Sep 11, 26 | K260115510(k) | DRIM-Nail System | 41Medical AG | Unknown | |
| Sep 11, 26 | K260410510(k) | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Gastroenterology, Urology | FED |
| Sep 11, 26 | K261019510(k) | ANTERION | Heidelberg Engineering GmbH | Ophthalmic | OBO |
| Sep 11, 26 | K261255510(k) | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | Ophthalmic | MYC |
| Sep 11, 26 | K261305510(k) | MICSI-PET | Microstructure Imaging, Inc. | Radiology | KPS |
| Sep 11, 26 | K261338510(k) | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | General, Plastic Surgery | OMP |
| Sep 11, 26 | K261580510(k) | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | Cardiovascular | MLO |
| Sep 11, 26 | K261807510(k) | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | Cardiovascular | JOW |
| Sep 11, 26 | K261837510(k) | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | Microbiology | QOF |
| Sep 11, 26 | K262007510(k) | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | General, Plastic Surgery | QPC |
| Sep 11, 26 | K262025510(k) | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | Orthopedic | OVD |
| Sep 11, 26 | K262050510(k) | Vioseal X | Spident Co., Ltd. | Dental | KIF |
| Sep 11, 26 | K262151510(k) | SpaceOAR Flex System | Boston Scientific Corporation | Radiology | OVB |
| Sep 11, 26 | K262230510(k) | Mg OSTEOREVIVE;Mg OSTEOCRETE | Bone Solutions, Inc. | Orthopedic | MQV |
| Sep 11, 26 | K262397510(k) | CuratOR EX2742 | Eizo Corporation | Gastroenterology, Urology | GCJ |
| Sep 11, 26 | K262763510(k) | iLet Dosing Decision Software | Beta Bionics, Inc. | Clinical Chemistry | QJI |
| Sep 11, 26 | K262861510(k) | PureLift Pro Max | Xtreem Pulse, LLC | Neurology | NFO |
| Sep 11, 26 | K262874510(k) | CraniUS Plate | CraniUS, LLC | Neurology | GWO |
| Sep 10, 26 | K253856510(k) | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | Neurology | HAW |
| Sep 10, 26 | K254009510(k) | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | Dental | SJH |
| Sep 10, 26 | K254074510(k) | TruPress | Procerus Enterprises | Cardiovascular | DRS |
| Sep 10, 26 | K254111510(k) | Irrigation/Urology Sets | B.Braun Medical, Inc. | Gastroenterology, Urology | LJH |
| Sep 10, 26 | K254246510(k) | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | General, Plastic Surgery | NAD |
| Sep 10, 26 | K260110510(k) | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | Gastroenterology, Urology | PIF |
| Sep 10, 26 | K260879510(k) | 4DM | INVIA, LLC | Radiology | QIH |
| Sep 10, 26 | K261409510(k) | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | Clinical Toxicology | NFT |
| Sep 10, 26 | K261562510(k) | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 10, 26 | K261696510(k) | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | Cardiovascular | OBJ |
| Sep 10, 26 | K261795510(k) | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | Radiology | QIH |
| Sep 10, 26 | K261929510(k) | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | Cardiovascular | DXN |
| Sep 10, 26 | K262079510(k) | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | Gastroenterology, Urology | FET |
| Sep 10, 26 | K262202510(k) | Cerasmart Forte | GC America, Inc. | Dental | EBF |
| Sep 10, 26 | K262293510(k) | EVOLUTION MPX Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | Orthopedic | JWH |
| Sep 10, 26 | K262426510(k) | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 9, 26 | K251417510(k) | ReVISION 2 | Argus Cognitive, Inc. | Radiology | QIH |
| Sep 9, 26 | K252486510(k) | ChestView US (1.1) | Gleamer | Radiology | MYN |
| Sep 9, 26 | K260652510(k) | ColActive Plus | Covalon Technologies, Ltd. | Unknown | KGN |
| Sep 9, 26 | K260997510(k) | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. | Gastroenterology, Urology | PLL |
| Sep 9, 26 | K261470510(k) | QF10 | E.A.M Benelux B.V | Gastroenterology, Urology | NHV |
| Sep 9, 26 | K261793510(k) | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | General Hospital | LZA |
| Sep 9, 26 | K262488510(k) | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Gastroenterology, Urology | FGB |
| Sep 9, 26 | K262542510(k) | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | General Hospital | LZA |
| Sep 8, 26 | K253988510(k) | LiteSet Trays | Nobel Biocare AB | General Hospital | KCT |
| Sep 8, 26 | K254294510(k) | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | Obstetrics/Gynecology | HIH |
| Sep 8, 26 | K260053510(k) | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | Physical Medicine | ITI |
| Sep 8, 26 | K260062510(k) | MODI System | DreaMed Diabetes, Ltd. | Clinical Chemistry | QRX |
| Sep 8, 26 | K260227510(k) | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | Radiology | KPR |
| Sep 8, 26 | K260229510(k) | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | Physical Medicine | ITI |
| Sep 8, 26 | K260312510(k) | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | General Hospital | LZA |
| Sep 8, 26 | K261462510(k) | LANDMARK Total Knee System | Smith & Nephew, Inc. | Orthopedic | MBH |
| Sep 8, 26 | K261715510(k) | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | Cardiovascular | PUM |
| Sep 8, 26 | K261823510(k) | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Sep 8, 26 | K261956510(k) | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | General, Plastic Surgery | PEM |
| Sep 8, 26 | K261987510(k) | Reusable SmartPeg | Osstell AB | Dental | EKX |
| Sep 8, 26 | K262173510(k) | N22 Offset Humeral Head | Shoulder Innovations, Inc. | Orthopedic | KWT |
| Sep 8, 26 | K262341510(k) | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | Orthopedic | JWH |
| Sep 6, 26 | K260396510(k) | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | Neurology | OBP |
| Sep 6, 26 | K261131510(k) | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) | Shenzhen Osto Medical Technology Co.,Ltd | Neurology | NUH |
| Sep 5, 26 | K254135510(k) | LipoSurg ARTIST | NOUVAG AG | General, Plastic Surgery | QPB |
| Sep 5, 26 | K261684510(k) | FreezeSpray TA | Cryosurgery, Inc. | Unknown | MLY |
| Sep 4, 26 | K253529510(k) | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | Cardiovascular | MWJ |
| Sep 4, 26 | K253836510(k) | FCT iStream Phase 2 | Fujifilm Corporation | Radiology | JAK |
| Sep 4, 26 | K253909510(k) | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | Dental | KIF |
| Sep 4, 26 | K254262510(k) | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | Microbiology | PSZ |
| Sep 4, 26 | K254264510(k) | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Microbiology | QVF |
| Sep 4, 26 | K260035510(k) | Digital Indeflator INFLANTE | UAB Telemedicina | Cardiovascular | MAV |
| Sep 4, 26 | K260331510(k) | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | Immunology | DHB |
| Sep 4, 26 | K260525510(k) | NextMR Spine | MRI2CT, Inc. | Radiology | QIH |
| Sep 4, 26 | K260756510(k) | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | Gastroenterology, Urology | EZL |
| Sep 4, 26 | K261057510(k) | ActivaScrew Cannulated COM | Bioretec, Ltd. | Orthopedic | HWC |
| Sep 4, 26 | K261935510(k) | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | General Hospital | KCT |
| Sep 4, 26 | K262060510(k) | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | Radiology | LLZ |
| Sep 4, 26 | K262130510(k) | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | Orthopedic | JWH |
| Sep 4, 26 | K262235510(k) | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | Medtronic Xomed, Inc. | Neurology | PGW |
| Sep 4, 26 | K262277510(k) | 70 NeuGlide Catheter | Piraeus Medical, Inc. | Cardiovascular | QJP |
| Sep 4, 26 | K262292510(k) | Gastric Alimetry | Alimetry , Ltd. | Gastroenterology, Urology | MYE |
| Sep 4, 26 | K262828510(k) | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB |
| Sep 3, 26 | DEN250044510(k) | Queen of Hearts (ACS AI ECG Model) | Powerful Medical, Inc. | Unknown | SHS |
| Sep 3, 26 | K251794510(k) | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Anesthesiology | BTR |
| Sep 3, 26 | K253673510(k) | Mcare System (MW-20) | Marani Health, Inc. | Obstetrics/Gynecology | LQK |
| Sep 3, 26 | K253989510(k) | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. | Obstetrics/Gynecology | NUC |
| Sep 3, 26 | K254000510(k) | Happy Health Blood Pressure Monitor | Happy Health, Inc. | Cardiovascular | DXN |
| Sep 3, 26 | K254035510(k) | Mayumi Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | Cardiovascular | QEZ |
| Sep 3, 26 | K260503510(k) | Triton 1 System | Neptune Medical, Inc. | Gastroenterology, Urology | FDF |
| Sep 3, 26 | K261281510(k) | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | Cardiovascular | DQX |
| Sep 3, 26 | K261622510(k) | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | Obstetrics/Gynecology | HGX |
| Sep 3, 26 | K261647510(k) | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | Orthopedic | HRS |
| Sep 3, 26 | K261800510(k) | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | Cardiovascular | QEW |
| Sep 3, 26 | K262243510(k) | Profisil Free | Kettenbach GmbH & Co. KG | Dental | LBH |
| Sep 3, 26 | K262315510(k) | NeuroBlate System | Monteris Medical | General, Plastic Surgery | ONO |
| Sep 3, 26 | K262460510(k) | Rezum System | Boston Scientific | Gastroenterology, Urology | KNS |
| Sep 3, 26 | K262769510(k) | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | Orthocon, Inc. | Unknown | MTJ |
| Sep 2, 26 | K253065510(k) | Aevumed SUPERCYNCH Button System | Aevumed, Inc. | Orthopedic | MBI |
| Sep 2, 26 | K253948510(k) | Momentum Acetabular Cup System | United Orthopedic Corporation | Orthopedic | LZO |
| Sep 2, 26 | K254026510(k) | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | Ear, Nose, Throat | EOQ |
| Sep 2, 26 | K254090510(k) | I-View® | Hologic, Inc. | Radiology | MUE |
| Sep 2, 26 | K254198510(k) | Trexo Theo | Trexo Robotics, Inc. | Physical Medicine | PHL |
| Sep 2, 26 | K260432510(k) | Ruby Intravascular Catheter | Venocare, Inc. | General Hospital | FOZ |
| Sep 2, 26 | K261311510(k) | HYALOMATRIX | Anika Therapeutics, Inc. | Unknown | QSZ |
| Sep 2, 26 | K261313510(k) | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Sep 2, 26 | K261589510(k) | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 2, 26 | K261749510(k) | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | General Hospital | LZA |
| Sep 2, 26 | K262153510(k) | Pivot Insulin Delivery System | Modular Medical, Inc. | General Hospital | LZG |
| Sep 2, 26 | K262364510(k) | Ellian Enigma RF Device | Ellian Corp | General, Plastic Surgery | GEI |
| Sep 2, 26 | K262420510(k) | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | General, Plastic Surgery | GEH |
| Sep 2, 26 | K262809510(k) | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | Orthopedic | MBI |
| Sep 1, 26 | K253961510(k) | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | Orthopedic | JWH |
| Sep 1, 26 | K260613510(k) | AMI Plasma Cartridge, AMI | Sequitur Health Corp. | Clinical Chemistry | JID |
| Sep 1, 26 | K260656510(k) | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | Cardiovascular | MHX |
| Sep 1, 26 | K260758510(k) | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | LNH |
| Sep 1, 26 | K260884510(k) | UNIDRIVE Select System | Karl Storz SE & CO. KG | Gastroenterology, Urology | GCJ |
| Sep 1, 26 | K261811510(k) | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. | General, Plastic Surgery | QSO |
| Sep 1, 26 | K262269510(k) | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 1, 26 | K262451510(k) | Arthrex DynaNite Staples | Arthrex, Inc. | Orthopedic | JDR |
| Sep 1, 26 | K262774510(k) | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | Obstetrics/Gynecology | HGX |
| Sep 1, 26 | K262783510(k) | RadiForce MX247W | Eizo Corporation | Radiology | PGY |
October 2026
September 2026
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.