FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
2017–2040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074 · CJE
Truvian Health
Chemistry · 255d
Cleared Dec 19, 2025
Pectus Versa System
K251050 · HRS
Gm Dos Reis Industria E Comercio
Orthopedic · 260d
Cleared Dec 19, 2025
Rectal Applicator
K251037 · JAQ
Nucletron B.V.
Radiology · 260d
Cleared Dec 19, 2025
Chiavaye Personal Moisturizer
K251011 · NUC
Unipack, LLC
Obstetrics & Gynecology · 262d
Cleared Dec 19, 2025
CO2 Laser Therapy System (Model: LFS-D9U)
K250998 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 262d
Cleared Dec 19, 2025
Airbile-100
K250976 · IZL
Poskom Co., Ltd.
Radiology · 263d
Cleared Dec 19, 2025
MatriDerm pluS+ Bi-Layer
K250864 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 273d
Cleared Dec 19, 2025
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
K250314 · PNE
Surgical Instrument Service and...
Cardiovascular · 318d
Cleared Dec 19, 2025
Vivo 45 LS
K232365 · CBK
Oconnell Regulatory Consultants, Inc.
Anesthesiology · 865d
Cleared Dec 18, 2025
MOVIVA® Hybrid Ablation Probe
K253915 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 10d
Cleared Dec 18, 2025
Dental Cone
K253758 · OLR
Medizin Produkte Neustadt GmbH (Mpn)
Dental · 23d
Cleared Dec 18, 2025
FX CorAL 40
K253518 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 36d
Cleared Dec 18, 2025
Assert-IQ (DM5100)
K253516 · MXD
Abbott Medical
Cardiovascular · 36d
Cleared Dec 18, 2025
Park Dental Nylon MAD
K252976 · LRK
Park Dental Research Corp.
Dental · 92d
Cleared Dec 18, 2025
Helo Thrombectomy System
K252956 · QEW
Endovascular Engineering, Inc.
Cardiovascular · 93d
Cleared Dec 18, 2025
ARMI® Endoscopic Video Image Processor (JY-MIP-3000)
K252793 · HIH
Jiangsu Jiyuan Medical Technology...
Obstetrics & Gynecology · 111d
Cleared Dec 18, 2025
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1
K252533 · DQK
Edwards Lifesciences
Cardiovascular · 128d
Cleared Dec 18, 2025
Midline Catheter
K252402 · PND
Terumo Medical Products Hangzhou Co.,...
General Hospital · 140d
Cleared Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
K252348 · MXK
Tomey Corporation
Ophthalmic · 142d
Cleared Dec 18, 2025
SIMDA Abutments
K252320 · NHA
Simda Co., Ltd.
Dental · 146d
Cleared Dec 18, 2025
PVAD IQ Software
K252235 · QIH
Ultrasight , Ltd.
Radiology · 154d
Cleared Dec 18, 2025
RefleXion Medical Radiotherapy System, Reflexion X2
K252071 · QVA
Reflexion Medical, Inc.
Radiology · 170d
Cleared Dec 18, 2025
Amethyst HP PTA OTW 0.035 Catheter
K251915 · LIT
Natec Medical , Ltd.
Cardiovascular · 178d
Cleared Dec 18, 2025
OTSCneo System Set (100.03n-14n, 100.27n-31n)
K251562 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 210d