The Tracker // August 2026
August 2026: 122 FDA device decisions
120 510(k) clearances and 2 original PMA approvals with a decision date in August 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Aug 16, 26 | K260563510(k) | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | Neurology | OLX |
| Aug 14, 26 | K253562510(k) | medilogFD | Schiller AG | Cardiovascular | MWJ |
| Aug 14, 26 | K253747510(k) | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | General Hospital | FMF |
| Aug 14, 26 | K260171510(k) | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | Anesthesiology | CAW |
| Aug 14, 26 | K260374510(k) | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | Neurology | GYD |
| Aug 14, 26 | K260438510(k) | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | Cardiovascular | MWI |
| Aug 14, 26 | K260559510(k) | NHanceIT | IMDS Operation B.V. | Cardiovascular | DQY |
| Aug 14, 26 | K260898510(k) | Transpara (2.1.0) | Screenpoint Medical B.V. | Radiology | QDQ |
| Aug 14, 26 | K261228510(k) | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | Neurology | OBP |
| Aug 14, 26 | K261428510(k) | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | Cardiovascular | LOX |
| Aug 14, 26 | K261646510(k) | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Unknown | FRO |
| Aug 14, 26 | K261890510(k) | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Gastroenterology, Urology | KNT |
| Aug 14, 26 | K262419510(k) | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | Neurology | HCG |
| Aug 14, 26 | K262424510(k) | Willow 12 Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Aug 14, 26 | K262449510(k) | AdvaView | ADVAHEALTH SOLUTIONS, LLC | Radiology | LLZ |
| Aug 14, 26 | K262452510(k) | AutoContour (RADAC V6) | Radformation, Inc. | Radiology | QKB |
| Aug 14, 26 | K262552510(k) | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Aug 14, 26 | K262571510(k) | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Gastroenterology, Urology | KNW |
| Aug 14, 26 | K262639510(k) | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | Orthopedic | QLQ |
| Aug 13, 26 | K253425510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | Cardiovascular | DXN |
| Aug 13, 26 | K253790510(k) | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | Physical Medicine | NGX |
| Aug 13, 26 | K253795510(k) | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | Ophthalmic | LPN |
| Aug 13, 26 | K253808510(k) | AIR Recon DL | GE Medical Systems | Radiology | LNH |
| Aug 13, 26 | K254201510(k) | Any-Cem | Mediclus Co., Ltd. | Dental | EMA |
| Aug 13, 26 | K260211510(k) | Dashboard (P007000) | Hill-Rom, Inc. | Cardiovascular | MSX |
| Aug 13, 26 | K260277510(k) | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | Orthopedic | HRS |
| Aug 13, 26 | K260413510(k) | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | Ear, Nose, Throat | KLW |
| Aug 13, 26 | K260907510(k) | BIS Advance pEEG Module | Covidien LP | Neurology | OLW |
| Aug 13, 26 | K261061510(k) | BP Go (BPP-855) | Wellvii, Inc. | Cardiovascular | DXN |
| Aug 13, 26 | K261139510(k) | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Gastroenterology, Urology | GCJ |
| Aug 13, 26 | K261499510(k) | TrachFlush | Aw Technologies Aps | Anesthesiology | BSK |
| Aug 13, 26 | K261626510(k) | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | Dental | EBI |
| Aug 13, 26 | K262398510(k) | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | Cardiovascular | NRY |
| Aug 12, 26 | K251641510(k) | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | Anesthesiology | CCK |
| Aug 12, 26 | K253417510(k) | Masimo Root Monitoring System | Masimo Corporation | Cardiovascular | MWI |
| Aug 12, 26 | K253846510(k) | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | General, Plastic Surgery | OAB |
| Aug 12, 26 | K260086510(k) | CadAI-B Dx | BeamWorks, Inc. | Radiology | QDQ |
| Aug 12, 26 | K260944510(k) | ManaCold Compression System | Manamed, LLC | Physical Medicine | IRP |
| Aug 12, 26 | K261170510(k) | BA-004CC | Fujifilm Corporation | Radiology | ITX |
| Aug 12, 26 | K261916510(k) | NeuroQuant PET | Cortechs Labs, Inc. | Radiology | LLZ |
| Aug 12, 26 | K262344510(k) | Large Compression Screws | TriMed, Inc. | Orthopedic | HWC |
| Aug 12, 26 | K262391510(k) | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | Cardiovascular | NRY |
| Aug 12, 26 | K262392510(k) | APRO 35 Swift Catheter | Alembic, LLC | Cardiovascular | DQY |
| Aug 12, 26 | K262399510(k) | Millipede System | Perfuze, Ltd. | Cardiovascular | NRY |
| Aug 12, 26 | K262406510(k) | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | General, Plastic Surgery | FTM |
| Aug 12, 26 | K262792510(k) | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | Gastroenterology, Urology | KNW |
| Aug 11, 26 | K253665510(k) | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | Unknown | FRO |
| Aug 11, 26 | K253985510(k) | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | Hematology | DAP |
| Aug 11, 26 | K261115510(k) | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | General, Plastic Surgery | QPC |
| Aug 11, 26 | K261398510(k) | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD |
| Aug 11, 26 | K261841510(k) | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Aug 11, 26 | K262472510(k) | Stelo Glucose Biosensor System | Dexcom, Inc. | Clinical Chemistry | SBH |
| Aug 10, 26 | K253468510(k) | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. | Gastroenterology, Urology | MPA |
| Aug 10, 26 | K253528510(k) | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | Immunology | NIG |
| Aug 10, 26 | K253794510(k) | Prostate Core | Lucida Medical, Ltd. | Radiology | QIH |
| Aug 10, 26 | K254036510(k) | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | Obstetrics/Gynecology | HGM |
| Aug 10, 26 | K254069510(k) | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | PKL |
| Aug 10, 26 | K254143510(k) | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | Radiology | ITX |
| Aug 10, 26 | K260094510(k) | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | INI |
| Aug 10, 26 | K260165510(k) | Unimpregnated Central Venous Catheter | Spectrum Vascular | General Hospital | FOZ |
| Aug 10, 26 | K260176510(k) | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | INI |
| Aug 10, 26 | K261576510(k) | Icona Hip Stem | Corin, Ltd. | Orthopedic | MEH |
| Aug 10, 26 | K261602510(k) | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 10, 26 | K261705510(k) | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Aug 10, 26 | K262427510(k) | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | General Hospital | FMI |
| Aug 10, 26 | P250042PMA | BAGUERA®C Cervical Disc Prosthesis | Spineart USA, Inc. | Orthopedic | MJO |
| Aug 7, 26 | K251544510(k) | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | Dental | EIA |
| Aug 7, 26 | K252571510(k) | mdprostate | Mediaire GmbH | Radiology | QIH |
| Aug 7, 26 | K253453510(k) | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | Microbiology | QWB |
| Aug 7, 26 | K253505510(k) | Zamenix P | Roen Surgical, Inc. | Gastroenterology, Urology | FGB |
| Aug 7, 26 | K253554510(k) | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | Pathology | PSY |
| Aug 7, 26 | K253561510(k) | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | Pathology | QKQ |
| Aug 7, 26 | K253702510(k) | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | Gastroenterology, Urology | FDS |
| Aug 7, 26 | K254205510(k) | Zenition 30 | Philips Medical Systems Nederland B.V. | Radiology | OWB |
| Aug 7, 26 | K260567510(k) | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | Gastroenterology, Urology | QNP |
| Aug 7, 26 | K260933510(k) | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | General Hospital | FMI |
| Aug 7, 26 | K261028510(k) | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | General, Plastic Surgery | FYA |
| Aug 7, 26 | K261362510(k) | Xpert Hemorrhagic Fever | Cepheid | Immunology | QVR |
| Aug 7, 26 | K261437510(k) | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | Cardiovascular | DWJ |
| Aug 7, 26 | K261563510(k) | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Aug 7, 26 | K261601510(k) | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 7, 26 | K261668510(k) | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Radiology | IYN |
| Aug 7, 26 | K261905510(k) | BUM Oil | Bumlicious, LLC (DBA Bumlicious) | Obstetrics/Gynecology | NUC |
| Aug 7, 26 | K261937510(k) | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | Dental | EMA |
| Aug 7, 26 | K262357510(k) | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | Orthopedic | MAI |
| Aug 6, 26 | K251508510(k) | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | Cardiovascular | MHX |
| Aug 6, 26 | K253469510(k) | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | Gastroenterology, Urology | FIE |
| Aug 6, 26 | K253999510(k) | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | Dental | NHA |
| Aug 6, 26 | K254194510(k) | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | Microbiology | PAM |
| Aug 6, 26 | K260223510(k) | Aristotle Mini Guidewire | Scientia Vascular, Inc. | Cardiovascular | MOF |
| Aug 6, 26 | K261059510(k) | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | Radiology | MYN |
| Aug 6, 26 | K261121510(k) | Megalodon Dynamic Compression System | Paragon 28, Inc. | Orthopedic | JDR |
| Aug 6, 26 | K261571510(k) | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Physical Medicine | IOR |
| Aug 6, 26 | K261898510(k) | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Orthopedic | KRO |
| Aug 5, 26 | K252853510(k) | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | Gastroenterology, Urology | QNP |
| Aug 5, 26 | K253858510(k) | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | Orthopedic | HWC |
| Aug 5, 26 | K254211510(k) | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | Unknown | |
| Aug 5, 26 | K260120510(k) | NaturaJel Oral Wound Care Kit | HCS Innovation, LLC | Unknown | OLR |
| Aug 5, 26 | K260737510(k) | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | Gastroenterology, Urology | EZD |
| Aug 5, 26 | K260845510(k) | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | General Hospital | MMK |
| Aug 5, 26 | K260919510(k) | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | Gastroenterology, Urology | KNY |
| Aug 5, 26 | K261380510(k) | Concentriq AP-Dx | Proscia, Inc. | Pathology | QKQ |
| Aug 5, 26 | K261456510(k) | Ruthinium Disc | Dental Manufacturing S.p.A. | Dental | POW |
| Aug 5, 26 | K261932510(k) | Leksell® Vantage Stereotactic System | Elekta Solutions AB | Neurology | HAW |
| Aug 5, 26 | K262056510(k) | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | Gastroenterology, Urology | EZL |
| Aug 5, 26 | P220015PMA | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | Tianjin MasterVision Technology Co., Ltd. | Ophthalmic | NUU |
| Aug 4, 26 | K253760510(k) | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | General Hospital | MRH |
| Aug 4, 26 | K253902510(k) | RealGUIDE | 3DIEMME SRL | Radiology | QIH |
| Aug 4, 26 | K254043510(k) | TRIVANCE Hip Stem | Globus Medical, Inc. | Orthopedic | LPH |
| Aug 4, 26 | K260572510(k) | Marrow Marxman | Medimetrix, LLC | Gastroenterology, Urology | KNW |
| Aug 4, 26 | K261496510(k) | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | General, Plastic Surgery | OHS |
| Aug 4, 26 | K261523510(k) | Vertex Thrombectomy System | Jupiter Endovascular | Cardiovascular | QEW |
| Aug 4, 26 | K261851510(k) | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 4, 26 | K262311510(k) | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Aug 3, 26 | K260236510(k) | XLITE | GEMSS HEALTHCARE CO., LTD. | Radiology | IZL |
| Aug 3, 26 | K260381510(k) | Eve | Wandercraft SAS | Physical Medicine | PHL |
| Aug 3, 26 | K261408510(k) | SABER-XA System | Elevation Spine | Orthopedic | OVD |
| Aug 3, 26 | K261503510(k) | PuraStat GI | 3-D Matrix, Inc. | General, Plastic Surgery | QAU |
| Aug 3, 26 | K261504510(k) | PuraStat-RM | 3-D Matrix, Inc. | Unknown | PHN |
| Aug 3, 26 | K261856510(k) | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | Radiology | IYE |
| Aug 3, 26 | K262047510(k) | Grappler Suture Anchor System | Paragon 28, Inc. | Orthopedic | MBI |
| Aug 3, 26 | K262115510(k) | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | Cardiovascular | IZQ |
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.