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
70537–70560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2003
CARDICARE MODEL MT-301F & MT-301C
K032714 · FLL
Lumiscope Co., Inc.
General Hospital · 50d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · LPH
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 22, 2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT...
K032929 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 22, 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION...
K032941 · IPF
Rich-Mar Corp.
Physical Medicine · 30d
Cleared Oct 22, 2003
MEDI-HEAT INFANT HEEL WARMER
K032989 · MPO
Mediheat, Inc.
Physical Medicine · 28d
Cleared Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 21, 2003
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · JIL
Analyticon Biotechnologies AG
Chemistry · 334d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · JDQ
Kinamed, Inc.
Orthopedic · 270d
Cleared Oct 21, 2003
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES...
K030348 · FIP
Biolab Equipment Canada , Ltd.
Gastroenterology & Urology · 260d
Cleared Oct 21, 2003
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K032074 · JJY
Cliniqa Corporation
Chemistry · 106d
Cleared Oct 21, 2003
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...
K032166 · GQG
Binax, Inc.
Microbiology · 97d
Cleared Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312 · DQY
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 21, 2003
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K032337 · GWM
Hemedex Incorporated
Neurology · 84d
Cleared Oct 21, 2003
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K032351 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared Oct 21, 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · EBZ
Satelec
Dental · 71d
Cleared Oct 21, 2003
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
K032608 · JIS
Gonotec Gesellschaft Fuer Mess-Und...
Chemistry · 57d
Cleared Oct 21, 2003
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
K032917 · HAW
Orthosoft, Inc.
Neurology · 29d
Cleared Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
K032974 · IYN
General Electric Co.
Radiology · 27d
Cleared Oct 21, 2003
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
K032985 · NBW
Hmd Biomedical, Inc.
Chemistry · 27d
Cleared Oct 21, 2003
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K033253 · GZJ
Micro Current Technology, Inc.
Neurology · 13d
Cleared Oct 20, 2003
FIT CHECKER II
K032289 · ELW
GC America, Inc.
Dental · 88d
Cleared Oct 20, 2003
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD...
K032819 · JJX
Bionostics, Inc.
Chemistry · 40d
Cleared Oct 20, 2003
EPT CERTAINTY PREGNANCY TEST
K032939 · LCX
Unipath , Ltd.
Chemistry · 28d