Search FDA 510(k) Devices

5,441 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1465–1488 of 174,061
Cleared Oct 08, 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
K252874 · KTI
Serpex Medical, Inc.
Anesthesiology · 28d
Cleared Oct 08, 2025
14Fr Low Profile Introducer Kit
K252766 · DYB
Abiomed, Inc.
Cardiovascular · 40d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Oct 08, 2025
The Botticelli (Model: Athena)
K251699 · GEX
Bellamia Technologies, Inc.
General & Plastic Surgery · 128d
Cleared Oct 08, 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 154d
Cleared Oct 08, 2025
ProKnow DS
K251363 · LLZ
Elekta Solutions AB
Radiology · 160d
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Oct 08, 2025
MetaFore Small Screw System
K250536 · HWC
Extremity Medical, LLC
Orthopedic · 226d
Cleared Oct 08, 2025
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298 · HDB
Clinical Innovations, LLC
Obstetrics & Gynecology · 250d
Cleared Oct 08, 2025
GT300
K250060 · OAS
Genoray Co., Ltd.
Radiology · 271d
Cleared Oct 07, 2025
TrueBeam, TrueBeam STX, Edge and VitalBeam
K252948 · IYE
Varian Medical Systems, Inc.
Radiology · 21d
Cleared Oct 07, 2025
deepLive (OSP12 + DMS)
K252851 · NQQ
Damae Medical
General & Plastic Surgery · 29d
Cleared Oct 07, 2025
Prodeon Urethral Sheath System
K252572 · FED
Prodeon Medical, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 07, 2025
AIAS Cephalon
K252214 · QIH
Metamorphosis GmbH
Radiology · 84d
Cleared Oct 07, 2025
Ultrasonic Bipolar Generator (USG-410)
K252150 · GEI
Olympus Medical Systems Corporation
General & Plastic Surgery · 90d
Cleared Oct 07, 2025
Eminent Spine Posterior SI System
K250894 · OUR
Eminent Spine
Orthopedic · 196d
Cleared Oct 07, 2025
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US)
K250688 · GEI
Acotec Scientific Co., Ltd.
General & Plastic Surgery · 215d
Cleared Oct 07, 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)...
K250364 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 239d
Cleared Oct 07, 2025
Disposable Hot Biopsy Forceps (FD-210U)
K250187 · KGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 258d
Cleared Oct 07, 2025
Ultrasound Therapy Workstation (XMS-UET2)
K244041 · IMG
Xemis Medical Technology (Shenzhen)...
Physical Medicine · 281d
Cleared Oct 06, 2025
Folding Mobility Scooter (KD101)
K252502 · INI
Nanjing Kangni Smart Technology Co.,...
Physical Medicine · 59d
Cleared Oct 06, 2025
Heylo™ System
K252140 · EXB
Coloplast Corp.
Gastroenterology & Urology · 90d
Cleared Oct 06, 2025
BlineSlide
K252007 · QIH
Deep Breathe, Inc.
Radiology · 101d
Cleared Oct 06, 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · NRY
Rapid Medical , Ltd.
Neurology · 132d