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
138241–138264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · JDG
Howmedica Corp.
Orthopedic · 26d
Cleared Sep 23, 1987
MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
K873542 · JTC
Genetic Systems Corp.
Microbiology · 22d
Cleared Sep 22, 1987
LINDEN STONE EXTRACTION BALLOON
K872509 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 22, 1987
MODIFIED CHLAMYSET ANTIGEN
K872744 · LJP
Orion Corp.
Microbiology · 74d
Cleared Sep 22, 1987
TENS PALS PLUS
K872976 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 54d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR W/5% SB & CHLORAMPHENICOL
K873233 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR W/C&C - PRODUCT #P3407
K873234 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004
K873235 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904
K873236 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR SLANT W/6% SB CHLORAMPHENIC
K873237 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450
K873238 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463
K873239 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T3285
K873240 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM
K873241 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM
K873242 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286
K873243 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP
K873244 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
K873249 · LKJ
Cytotech, Inc.
Immunology · 36d
Cleared Sep 22, 1987
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · KLT
Windsor Laboratories, Inc.
Toxicology · 36d
Cleared Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · LAN
Em Diagnostic Systems, Inc.
Toxicology · 33d
Cleared Sep 22, 1987
WAKO(TM) PRETEST 8A
K873553 · JJB
Wako Chemicals USA, Inc.
Chemistry · 25d
Cleared Sep 22, 1987
AUTO-EIA
K873583 · JJQ
Labsystems, Inc.
Chemistry · 19d
Cleared Sep 22, 1987
FINNIGAN MAT INCOS 50
K873603 · JJO
Finnigan Corp.
Chemistry · 18d
Cleared Sep 21, 1987
AN3200 DOUBILET DRAIN
K872458 · FGE
H.W. Andersen Products, Inc.
Gastroenterology & Urology · 90d