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
36025–36048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2014
3MP Color LCD monitor, RadiForce RS340
K143098 · PGY
Eizo Corporation
Radiology · 21d
Cleared Nov 18, 2014
Sentinella 102
K143156 · IYX
General Equipment For Medical Imaging...
Radiology · 15d
Cleared Nov 17, 2014
A-LINK Z
K133827 · OVD
Osteo Vasive, LLC
Orthopedic · 335d
Cleared Nov 17, 2014
SAIPH KNEE SYSTEM
K140222 · JWH
Matortho
Orthopedic · 292d
Cleared Nov 17, 2014
ASCEND ELECTRODE
K140586 · GXY
Neurometrix, Inc.
Neurology · 255d
Cleared Nov 17, 2014
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
K140595 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 17, 2014
CLINITEK NOVUS
K140717 · KQO
Siemens Healthcare Diagnostics
Chemistry · 242d
Cleared Nov 17, 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K141317 · PEK
Aurora Spine, Inc.
Orthopedic · 181d
Cleared Nov 17, 2014
SURGICAL GOWN
K141606 · FYA
Cobes Industries Co., Ltd.
General Hospital · 154d
Cleared Nov 17, 2014
PREMIER ETCH
K141839 · KLE
Premier Dental Products Co.
Dental · 132d
Cleared Nov 17, 2014
CUTANEOUS ELECTRODES
K142099 · GXY
Bio Protech, Inc.
Neurology · 108d
Cleared Nov 17, 2014
Speed, Speed Shift, Speed Titan, Speed Arc
K142292 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 91d
Cleared Nov 14, 2014
HEPARIN LOCK / FLUSH SYRINGES
K133446 · NZW
Excelsior Medical Corporation
General Hospital · 367d
Cleared Nov 14, 2014
TECOTHERM NEO (T NEO)
K140078 · DWJ
Inspiration Healthcare, Ltd.
Cardiovascular · 305d
Cleared Nov 14, 2014
RESPIRONICS REUSABLE HEATED TUBING
K140424 · BZE
Respironics, Inc.
Anesthesiology · 268d
Cleared Nov 14, 2014
MICRO GUIDE CATHETER ELITE
K140438 · PDU
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 266d
Cleared Nov 14, 2014
GARMENT ELECTRODES
K141076 · GXY
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 203d
Cleared Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · NUH
Well-Life Healthcare Limited
Neurology · 179d
Cleared Nov 14, 2014
CL DETECT RAPID TEST
K141341 · PIT
InBios International, Inc.
Microbiology · 177d
Cleared Nov 14, 2014
WEARABLE THERAPY GARMENTS
K141342 · GXY
Axiobionics, LLC
Neurology · 177d
Cleared Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
K141471 · JWH
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Nov 14, 2014
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · QEW
Rex Medical, L.P.
Cardiovascular · 150d
Cleared Nov 14, 2014
NUVASIVE NVM5 SYSTEM
K141968 · PDQ
Nuvasive, Inc.
Neurology · 116d
Cleared Nov 14, 2014
BULK FILL FLOWABLE COMPOSITE
K141994 · EBF
Novocol, Inc.
Dental · 115d