FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125449–125472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1990
CHOLESTEROL (RATE) REAGENT
K902098 · CHH
Sigma Chemical Co.
Chemistry · 93d
Cleared Aug 09, 1990
DOWD CATHETER
K902124 · FAH
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Aug 09, 1990
TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP
K902158 · DZE
Impla-Med
Dental · 86d
Cleared Aug 09, 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · JWH
Depuy, Inc.
Orthopedic · 83d
Cleared Aug 09, 1990
KM-5 METAL BACKED ACETABULAR CUP
K902279 · JDI
Kirschner Medical Corp.
Orthopedic · 79d
Cleared Aug 09, 1990
RASTRONICS PORTAREM 20
K902287 · EJT
Rastronics USA, Inc.
Dental · 79d
Cleared Aug 09, 1990
ABDOMINAL OR C-SECTION DRAPE SHEET
K902384 · KKX
Medical Plastics, Inc.
General Hospital · 71d
Cleared Aug 09, 1990
BIOCLOT C KIT
K902528 · GGP
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
SPECTROLYSE ATIII KIT
K902530 · JBQ
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
BIOPOOL PROTEIN C EID KIT AND BULK PLATES
K902566 · GGP
Biopool AB
Hematology · 59d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · LBR
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
K902569 · JJX
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
EZ-SCREEN:HCG
K902681 · JHI
Environmental Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · LZO
Osteonics Corp.
Orthopedic · 50d
Cleared Aug 09, 1990
AFFINITY HCG TEST SYSTEM
K902720 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Aug 09, 1990
LSF CEMENTED FEMORAL HIP
K902727 · JDI
Implant Technology, Inc.
Orthopedic · 49d
Cleared Aug 09, 1990
SEROZYME FREE T3 IMMUNOASSAY
K902748 · KHQ
Advanced Magnetics, Inc.
Toxicology · 48d
Cleared Aug 09, 1990
LAMINECTOMY ROGEUR
K902819 · LXH
Ruggles Corp.
Orthopedic · 43d
Cleared Aug 09, 1990
ARGENCO 10 TYPE I DENTAL GOLD ALLOY
K902899 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO M-1 TYPE II DENTAL GOLD ALLOY
K902900 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 16 TYPE I DENTAL GOLD ALLOY
K902901 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 17 TYPE II DENTAL GOLD ALLOY
K902903 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY
K902904 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · LFX
Vitek Systems, Inc.
Microbiology · 37d