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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165001–165024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1980
CMR 300, ROWATER TREATMENT UNIT
K802474 · FIP
U-Marc, Inc.
Gastroenterology & Urology · 67d
Cleared Dec 12, 1980
UPPER EXTREMITY TRACTION DEVICE
K803021 · HST
Orthopedic Systems, Inc.
Neurology · 16d
Cleared Dec 11, 1980
HEMATIC BLOOD MIXER
K802608 · KSQ
Helmer Labs, Inc.
Hematology · 51d
Cleared Dec 11, 1980
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · CFE
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Dec 11, 1980
CREATININE STANDARDS
K802631 · JIS
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
BUN/GLUCOSE STANDARDS
K802633 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · JOJ
Organon, Inc.
General Hospital · 50d
Cleared Dec 11, 1980
PLATELET COUNTING KIT
K802636 · GKL
Streck Laboratories, Inc.
Hematology · 49d
Cleared Dec 11, 1980
GAMMEX SURGICAL GLOVES
K802641 · KGO
Ansell, Inc.
General Hospital · 48d
Cleared Dec 11, 1980
SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.
K802704 · IYO
Cgr Medical Corp.
Radiology · 41d
Cleared Dec 11, 1980
GLYCOHEMOGLOBIN IN WHOLE BLOOD
K802721 · LCP
Sigma Chemical Co.
Hematology · 41d
Cleared Dec 11, 1980
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS
K802725 · KZR
Varian Assoc., Inc.
Chemistry · 41d
Cleared Dec 11, 1980
125I-TESTOSTERONE TEST SET
K802728 · CDZ
Wien Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · GGK
Miles Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)
K802753 · JSK
Oxoid U.S.A., Inc.
Chemistry · 38d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0765
K802769 · FCT
Aspen Laboratories, Inc.
Ophthalmic · 38d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0766766
K802770 · FCT
Aspen Laboratories, Inc.
Ophthalmic · 38d
Cleared Dec 11, 1980
ARGYLE CONNECT TUBE-CON & NON
K802777 · GAZ
Sherwood Medical Co.
General Hospital · 36d
Cleared Dec 11, 1980
ELASTIC BANDAGE
K802785 · FQM
Secol Co.
General Hospital · 37d
Cleared Dec 11, 1980
OPRATEX ABDOMINAL PAD
K802798 · GDY
Secol Co.
General & Plastic Surgery · 37d
Cleared Dec 11, 1980
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
K802821 · JBD
Beckman Instruments, Inc.
Hematology · 31d
Cleared Dec 11, 1980
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · JHO
Beckman Instruments, Inc.
Immunology · 31d
Cleared Dec 11, 1980
CHOLESTEROL STANDARDS
K802823 · JIT
Mallinckrodt Critical Care
Chemistry · 31d