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
77065–77088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2001
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K013193 · GEX
Biolitec, Inc.
General & Plastic Surgery · 88d
Cleared Dec 21, 2001
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
K013371 · JJQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 71d
Cleared Dec 21, 2001
NORMATEC PCD
K013436 · JOW
Normatec, Inc.
Cardiovascular · 66d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466 · JHO
Helena Laboratories
Chemistry · 64d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · HTO
Synthes (Usa)
Orthopedic · 59d
Cleared Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · DHX
Bayer Corp.
Immunology · 56d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606 · LPS
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV
Diamedix Corp.
Immunology · 46d
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · CIC
Wiener Laboratories Saic
Chemistry · 45d
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013800 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 36d
Cleared Dec 21, 2001
GLO-SPEC
K013817 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 35d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · JIT
Diamond Diagnostics, Inc.
Chemistry · 31d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900 · JJX
Ortho-Clinical Diagnostics
Toxicology · 28d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 37d
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995 · JJY
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 21, 2001
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
K014058 · LLZ
General Electric Medical Systems
Radiology · 11d
Cleared Dec 21, 2001
BIOSCANNER PLUS
K014099 · NBW
Polymer Technology Systems, Inc.
Chemistry · 8d
Cleared Dec 20, 2001
SAUFLON MULTI LENS CARE SYSTEM
K010559 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 297d
Cleared Dec 20, 2001
OXYLOG 1000, MODEL 2M86840
K010793 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 279d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · HRS
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 20, 2001
FILTERFLO H
K011212 · CAH
Arc Medical, Inc.
General Hospital · 244d
Cleared Dec 20, 2001
3D LINE STEROTACTIC HARDWARE ACCESSORIES
K011255 · HAW
3D Line USA, Inc.
Neurology · 240d