FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2353–2376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2025
cleadew GP hydra one
K251876 · MRC
Ophtecs Corporation
Ophthalmic · 113d
Cleared Oct 09, 2025
DIASAFEplusUS (F00013010)
K251851 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 115d
Cleared Oct 09, 2025
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
K251795 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 119d
Cleared Oct 09, 2025
EPIQ Series Diagnostic Ultrasound System
K251651 · IYN
Philips Ultrasound, LLC
Radiology · 133d
Cleared Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · OLT
Nihon Kohden Corporation
Neurology · 161d
Cleared Oct 09, 2025
SleeveLUX 24 Anoscope/Proctoscope (P2001)
K250645 · FER
Haemoband Surgical, Ltd.
Gastroenterology & Urology · 219d
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