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
69409–69432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2003
EXACTRAC GATING
K033287 · IYE
Brainlab AG
Radiology · 66d
Cleared Dec 19, 2003
DEGALL II GALLBLADDER EXTRACTOR
K033359 · GCJ
Surgicon, Inc.
General & Plastic Surgery · 59d
Cleared Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
K033379 · JJY
Bayer Diagnostics Corp.
Chemistry · 58d
Cleared Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64...
K033558 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033603 · LIG
Beckman Coulter, Inc.
Chemistry · 32d
Cleared Dec 19, 2003
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
K033657 · DRN
Living Data Technologies Corporation
Cardiovascular · 28d
Cleared Dec 19, 2003
SAFYRE VS AND SAFYRE T
K033691 · OTN
Promedon
Gastroenterology & Urology · 25d
Cleared Dec 19, 2003
HYDROPHILIC GUIDEWIRE
K033758 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Dec 19, 2003
ALLEGRO IMAGING SYSTEM
K033782 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Dec 19, 2003
PLASMACURE BXE
K033795 · EBZ
Eele Laboratories, LLC
Dental · 14d
Cleared Dec 19, 2003
SIENET COSMOS
K033831 · LLZ
Siemens AG Medical Solutions
Radiology · 9d
Cleared Dec 19, 2003
T-TECH DIGITAL, MODEL WL-22XXA SERIES
K033857 · GZJ
Well-Life Healthcare, Inc.
Neurology · 8d
Cleared Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · LNH
General Electric Co.
Radiology · 7d
Cleared Dec 18, 2003
COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
K031618 · IPL
Comfort Orthopedic Co., Ltd.
Physical Medicine · 209d
Cleared Dec 18, 2003
TANGO, MODELS, BP1
K031711 · ITI
American Bantex Corp.
Physical Medicine · 199d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · KRO
Biomet, Inc.
Orthopedic · 190d
Cleared Dec 18, 2003
BTG SMARTEST GLUCOSE TEST SYSTEM
K032029 · NBW
Bt Medical
Chemistry · 170d
Cleared Dec 18, 2003
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · GDW
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · FZP
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2003
VISU-LOCK 5MM CLIP APPLIER
K033161 · FZP
Gyrx, LLC
General & Plastic Surgery · 79d
Cleared Dec 18, 2003
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · ITI
Emg Technology Co., Ltd.
Physical Medicine · 77d
Cleared Dec 18, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
K033220 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 76d
Cleared Dec 18, 2003
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
K033240 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 73d
Cleared Dec 18, 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524 · HWC
Coapt Systems, Inc.
General & Plastic Surgery · 41d