Latest 510(k) clearances
Newest first, 50 per page. Open a clearance to see any recalls that name it.
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2026 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) Siemens Healthcare Diagnostic Products GmbH, DE | DAP |
| Aug 11, 2026 | K253665 | Vashe Plus Antimicrobial Solution Urgo Medical North America, LLC | FRO |
| Aug 10, 2026 | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safet Hh Global Technology, Inc. | FMI |
| Aug 10, 2026 | K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) Shenzhen Jianchao Intelligent Technology Co., Ltd., CN | OHT |
| Aug 10, 2026 | K261602 | Eye Recovery Pro (PH-e03) Shenzhen Goodwind Technology Development Co., Ltd., CN | OHS |
| Aug 10, 2026 | K261576 | Icona Hip Stem Corin, Ltd., GB | MEH |
| Aug 10, 2026 | K260176 | Mobility Scooter (W3483, W3483A) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, CN | INI |
| Aug 10, 2026 | K260165 | Unimpregnated Central Venous Catheter Spectrum Vascular | FOZ |
| Aug 10, 2026 | K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, CN | INI |
| Aug 10, 2026 | K254143 | EM-TECH Passive Ultrasound Probe Strap EM-TECH Solutions, Inc. | ITX |
| Aug 10, 2026 | K254069 | Hemoclip (511 series, 543 series) Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Aug 10, 2026 | K254036 | Novii+ Wireless Patch System Datex Ohmeda, Inc. | HGM |
| Aug 10, 2026 | K253794 | Prostate Core Lucida Medical, Ltd., GB | QIH |
| Aug 10, 2026 | K253528 | Atellica IM CA 19-9 II Siemens Healthcare Diagnostics, Inc. | NIG |
| Aug 10, 2026 | K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) Nova Eye, Inc. | MPA |
| Aug 7, 2026 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc. | MAI |
| Aug 7, 2026 | K261937 | PacTemp Automix NE The Belport Company Inc., DBA Gingi-Pak | EMA |
| Aug 7, 2026 | K261905 | BUM Oil Bumlicious, LLC (DBA Bumlicious) | NUC |
| Aug 7, 2026 | K261668 | Venue Go GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | IYN |
| Aug 7, 2026 | K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Shenzhen Chuangtong Yigou Technology Co., Ltd., CN | OHS |
| Aug 7, 2026 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) Maxx Orthopedics, Inc. | JWH |
| Aug 7, 2026 | K261437 | Mistral-Air® Warming System The Surgical Company International B.V., doing business as TSC Life, NL | DWJ |
| Aug 7, 2026 | K261362 | Xpert Hemorrhagic Fever Cepheid | QVR |
| Aug 7, 2026 | K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) Yadu Medical (Henan) Co., Ltd., CN | FYA |
| Aug 7, 2026 | K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051 Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN | FMI |
| Aug 7, 2026 | K260567 | EW10-EC02 Endoscopy Support Program Fujifilm Corporation, JP | QNP |
| Aug 7, 2026 | K254205 | Zenition 30 Philips Medical Systems Nederland B.V., NL | OWB |
| Aug 7, 2026 | K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) Intuitive Surgical, Inc. | FDS |
| Aug 7, 2026 | K253561 | Aperio iQC DX Software Leica Biosystems Imaging, Inc. | SIX |
| Aug 7, 2026 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX Leica Biosystems Imaging, Inc. | PSY |
| Aug 7, 2026 | K253505 | Zamenix P Roen Surgical, Inc., KR | FGB |
| Aug 7, 2026 | K253453 | Metrix COVID Test; Metrix COVID Test Pro Aptitude Medical Systems, Inc. | QWB |
| Aug 7, 2026 | K252571 | mdprostate Mediaire GmbH, DE | QIH |
| Aug 7, 2026 | K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) Lakong Medical Devices Co., Ltd., CN | EIA |
| Aug 6, 2026 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Howmedica Osteonics Corp. dba Stryker Orthopaedics | KRO |
| Aug 6, 2026 | K261571 | Manual Wheelchair (H008, PCK7) Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN | IOR |
| Aug 6, 2026 | K261121 | Megalodon Dynamic Compression System Paragon 28, Inc. | JDR |
| Aug 6, 2026 | K261059 | Overjet Multi-Image Caries and Charting Assist Overjet, Inc. | MYN |
| Aug 6, 2026 | K260223 | Aristotle Mini Guidewire Scientia Vascular, Inc. | MOF |
| Aug 6, 2026 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel QIAGEN GmbH, DE | PAM |
| Aug 6, 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and No Nobel Biocare AB, SE | NHA |
| Aug 6, 2026 | K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Refl Mozarc Medical Us, LLC | FIE |
| Aug 6, 2026 | K251508 | Telemetry Monitor (iT30, iT50) Edan Instruments, Inc., CN | MHX |
| Aug 5, 2026 | K262056 | Rusch Latex Gold Foley Catheter Teleflex Medical Sdn. Bhd., MY | EZL |
| Aug 5, 2026 | K261932 | Leksell® Vantage Stereotactic System Elekta Solutions AB, SE | HAW |
| Aug 5, 2026 | K261456 | Ruthinium Disc Dental Manufacturing S.p.A., IT | POW |
| Aug 5, 2026 | K261380 | Concentriq AP-Dx Proscia, Inc. | QKQ |
| Aug 5, 2026 | K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) Class Medical , Ltd., IE | KNY |
| Aug 5, 2026 | K260845 | Huahong Sharps Container (HHR-I, HHR-II) Tianjin Huahong Technology Co., Ltd., CN | MMK |
| Aug 5, 2026 | K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Inte Convatec, GB | EZD |