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
118105–118128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1992
KEITH A-GAURD
K915107 · LYY
Kbk Medical Products, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
GUIDE WIRE EXTENSION
K915114 · DQX
Target Therapeutics
Cardiovascular · 90d
Cleared Feb 11, 1992
UNIVERSAL COMPRESION SCREW
K915124 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Feb 11, 1992
LATEX MED.EXAM.GLOVES POWDERED AMBIDEXTROUS
K915126 · LYY
Hedd Roz Canada, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT
K915127 · LYY
Hedd Roz Canada, Inc.
General Hospital · 90d
Cleared Feb 11, 1992
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
K915132 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Feb 11, 1992
PRIMARY DRESSING TRAY
K915140 · LYY
Mediflex Intl.
General Hospital · 90d
Cleared Feb 11, 1992
SOLUTION SYSTEM CUP
K915216 · JDI
Depuy, Inc.
Orthopedic · 85d
Cleared Feb 11, 1992
DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL
K915228 · CCK
Hospitak, Inc.
Anesthesiology · 83d
Cleared Feb 11, 1992
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
K915297 · HET
Lifeguard Medical Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 11, 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · GFO
International Technidyne Corp.
Hematology · 77d
Cleared Feb 11, 1992
PTA BALLOON CATHETER
K915349 · LIT
Schneider Intl., Ltd.
Cardiovascular · 77d
Cleared Feb 11, 1992
ULTRA R-11 CRUISER
K915609 · ITI
Brookefield Hunter, Inc.
Physical Medicine · 68d
Cleared Feb 11, 1992
TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST.
K915637 · IRP
Progressive Medical Technology, Inc.
Physical Medicine · 56d
Cleared Feb 11, 1992
TALLEY TM200 INTERMTTENT COMPRESSION UNIT
K915638 · IRP
Progressive Medical Technology, Inc.
Physical Medicine · 56d
Cleared Feb 11, 1992
SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030
K915768 · GEX
Surgical Laser Products, Inc.
General & Plastic Surgery · 49d
Cleared Feb 11, 1992
CORDIS SHUTTLE CATHETER
K915777 · DQY
Cordis Corp.
Cardiovascular · 49d
Cleared Feb 11, 1992
CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
K915836 · DQO
Cordis Corp.
Cardiovascular · 49d
Cleared Feb 11, 1992
SUNGLASSES (NON-PRESCRIPTION)
K920165 · HQY
Blair Corporation
Ophthalmic · 28d
Cleared Feb 11, 1992
CURAD KID SIZE INSTANT COLD PACK
K920252 · IMD
Kendall Healthcare Products Co....
Physical Medicine · 21d
Cleared Feb 11, 1992
JACE MODEL W550 WRIST CPM DEVICE
K920380 · BXB
Jace Systems, Inc.
Physical Medicine · 13d
Cleared Feb 11, 1992
VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR
K920391 · IOR
Invacare Corp.
Physical Medicine · 12d
Cleared Feb 07, 1992
COMFORTRON PT (TENS)
K911066 · GZI
M. D. Supply, Inc.
Neurology · 333d
Cleared Feb 07, 1992
SUPERLOGGER
K912772 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 228d