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
69457–69480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2003
LOTUS
K032424 · LFL
Sra Developments, Ltd.
General & Plastic Surgery · 133d
Cleared Dec 16, 2003
AESKULISA ANA 8PRO
K032469 · LLL
Aesku, Inc.
Immunology · 127d
Cleared Dec 16, 2003
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
K032741 · GWF
Axon Systems, Inc.
Neurology · 103d
Cleared Dec 16, 2003
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
K032909 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Dec 16, 2003
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
K032920 · DXT
Coeur Medical
Cardiovascular · 85d
Cleared Dec 16, 2003
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
K032994 · GZJ
Gemore Technology Co, Ltd.
Neurology · 82d
Cleared Dec 16, 2003
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
K033054 · MEA
Harvard Clinical Technology
General Hospital · 78d
Cleared Dec 16, 2003
BAYER SPECIAL CHEMISTRY CALIBRATORS
K033380 · JIX
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Dec 16, 2003
EVOLVE
K033551 · DYH
Reliance Orthodontic Products, Inc.
Dental · 36d
Cleared Dec 16, 2003
INSORB ABSORBABLE STAPLE, MODEL SP-B20
K033602 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 32d
Cleared Dec 16, 2003
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
K033793 · MCW
Rex Medical
Cardiovascular · 11d
Cleared Dec 15, 2003
ACCUSOFT
K032171 · IYE
Direx Systems Corp.
Radiology · 152d
Cleared Dec 15, 2003
EUSOL-C
K032422 · LYX
Al.Chi.Mi.A
Ophthalmic · 132d
Cleared Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · KWS
Tornier
Orthopedic · 108d
Cleared Dec 15, 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Dec 15, 2003
AUTOMOVE, MODEL AM800
K032955 · IPF
Danmeter A/S
Physical Medicine · 84d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · DKB
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348 · FGE
Cook, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 15, 2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
K033604 · IYO
Pie Medical
Radiology · 28d
Cleared Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ
Canon USA, Inc.
Radiology · 27d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631 · GGP
Instrumentation Laboratory CO
Hematology · 26d
Cleared Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY...
K033701 · MVN
Ciba Vision Corporation
Ophthalmic · 20d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 17d