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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69193–69216 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · NPR
Roche Diagnostics Corp.
Pathology · 31d
Cleared Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
K033672 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 18, 2003
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
K033709 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 22d
Cleared Dec 18, 2003
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · GAM
Ethicon, Inc.
General & Plastic Surgery · 17d
Cleared Dec 18, 2003
MODIFICATION TO SLIM GLIDING NAIL SYSTEM
K033763 · KTT
Plus Orthopedics
Orthopedic · 16d
Cleared Dec 18, 2003
UB 140
K033827 · ITI
Rivertrail Mobility
Physical Medicine · 8d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · LOD
Biomet, Inc.
Orthopedic · 342d
Cleared Dec 17, 2003
BAYER RAPIDLAB 1200 SYSTEM
K031560 · CHL
Bayer Healthcare, LLC
Chemistry · 212d
Cleared Dec 17, 2003
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
K032358 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 140d
Cleared Dec 17, 2003
MODIFICATION TO: NUCAMMA RX
K032779 · KPS
Is2 Research, Inc.
Radiology · 100d
Cleared Dec 17, 2003
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 86d
Cleared Dec 17, 2003
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE...
K032943 · KNW
Stryker Corp.
Gastroenterology & Urology · 86d
Cleared Dec 17, 2003
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
K033040 · FMT
International Hospital Supply Co.
General Hospital · 79d
Cleared Dec 17, 2003
CONDUCTIVE EEG ELECTROLYTE
K033052 · GYB
Compumedics USA, Ltd.
Neurology · 79d
Cleared Dec 17, 2003
(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
K033229 · LYZ
Bernard Technologies, Inc.
General Hospital · 72d