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
151561–151584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1984
HOLLOW FIBER DIALYZERS
K840845 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 174d
Cleared Aug 16, 1984
ACCU-CULT FECAL OCCULT BLOOD TEST
K840904 · KHE
Applied Medical Devices, Inc.
Hematology · 170d
Cleared Aug 16, 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · GKL
Diagnostic Technology, Inc.
Hematology · 78d
Cleared Aug 16, 1984
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 78d
Cleared Aug 16, 1984
TDX DIGITOXIN
K842280 · LFM
Abbott Laboratories
Toxicology · 69d
Cleared Aug 16, 1984
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · CGR
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · CGA
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 16, 1984
AXIOM STABLE II URIC ACID TEST
K842442 · KNK
Axiom, Inc.
Chemistry · 56d
Cleared Aug 16, 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
AMER. BIO-SCIENCE LAB CORTISOL REAGENT
K842455 · CGR
American Bio-Science Laboratories
Chemistry · 55d
Cleared Aug 16, 1984
DATA MGMT. SYSTEM
K842500 · JJE
Gilford
Chemistry · 51d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · LDP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN CALIBRATOR
K842549
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared Aug 16, 1984
IMMPULSE DIGOXIN ASSAY REAGENTS
K842571 · KXT
Aktis Corp.
Toxicology · 44d
Cleared Aug 16, 1984
EPSILON DIGOXIN TEST KIT
K842655 · KXT
Beckman Instruments, Inc.
Toxicology · 37d
Cleared Aug 16, 1984
STREPTEX DIRECT A ZL14
K842827 · GTZ
Wellcome Diagnostics
Immunology · 27d
Cleared Aug 15, 1984
COLOR OPTIC CORNEAL EYE SHIELD
K840414 · HOY
Diversations, Inc.
Ophthalmic · 197d
Cleared Aug 15, 1984
ACU220 CRYO UNIT
K841294 · HQA
Keller Instruments, Inc.
Ophthalmic · 139d
Cleared Aug 15, 1984
QUAZAR ESOPHAGEAL STETHOSCOPE
K841574 · BZW
Axiom Medical, Inc.
Anesthesiology · 120d
Cleared Aug 15, 1984
SIDE CUTTING SERRATED BLADE
K841980 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 93d
Cleared Aug 15, 1984
ACU-DERM TRANSPARENT IV DRESSING
K842064 · KMK
Acme United Corp.
General & Plastic Surgery · 86d
Cleared Aug 15, 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · KQO
Miles Laboratories, Inc.
Chemistry · 71d
Cleared Aug 15, 1984
ACTH NORMAL RANGE
K842249 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 70d