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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76681–76704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2002
CANVAS N-VAS-D 2.0
K014011 · LNH
Vassol, Inc.
Radiology · 62d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · LKY
Endocare, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 05, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · KWP
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 185d
Cleared Feb 04, 2002
ADVANCED AIR PURIFICATION SYSTEM
K012549 · FRF
Healthway Products, Inc.
General Hospital · 181d
Cleared Feb 04, 2002
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
K012676 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K012694 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT...
K013254 · LZA
Top Quality Mfg., Inc.
General Hospital · 129d
Cleared Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · FDS
Pentax Precision Instrument Corp.
Radiology · 91d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 04, 2002
BERCHTOLD ELEKTROTOM 106 HITT
K013668 · GEI
Berchtold Corp.
General & Plastic Surgery · 90d
Cleared Feb 04, 2002
ENDO-GLIDE
K013701 · GCJ
Sonotech, Inc.
General & Plastic Surgery · 88d
Cleared Feb 04, 2002
TEMPFIL
K013895 · EBG
Sybron Dental Specialties, Inc.
Dental · 73d
Cleared Feb 04, 2002
VERAVIEWEPOCS, MODEL VE
K013955 · EHD
J. Morita USA, Inc.
Radiology · 66d
Cleared Feb 04, 2002
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K014077 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 55d
Cleared Feb 04, 2002
DEMETRON LC
K014179 · EBZ
Kerr Corp.
Dental · 46d
Cleared Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 19d
Cleared Feb 01, 2002
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
K011901 · MKJ
Survivalink Corp.
Cardiovascular · 228d
Cleared Feb 01, 2002
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K012241 · DSI
Cardionet, Inc.
Cardiovascular · 199d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 193d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · JJF
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Feb 01, 2002
XENALIGHT MODELS # AX9125 (100-120V~)
K013511 · FSW
Aculux, Inc.
General & Plastic Surgery · 102d