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
151033–151056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1984
TOOTH ROOT SOCKET GAUGE
K843154 · LYC
Interpore Intl.
Dental · 52d
Cleared Oct 01, 1984
BIOLAS YAG 100 CILAS, ERCELAS YAG 100
K843156 · LNK
Advanced Biomedical Instruments
Gastroenterology & Urology · 52d
Cleared Oct 01, 1984
EI-CANDIDA ENZYME IMMUNOASSAY EI1001
K843286 · LRF
Immuno-Mycologics, Inc.
Microbiology · 41d
Cleared Oct 01, 1984
WELLINGTON HOSPITAL PATTERN SELF-RETAIN
K843388 · HDF
Downs Surgical , Ltd.
Obstetrics & Gynecology · 33d
Cleared Oct 01, 1984
ENCORE IGE REAGENT
K843408 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Oct 01, 1984
BONE PLATES
K843553 · KTW
Mecron Medical Products, Inc.
Orthopedic · 21d
Cleared Oct 01, 1984
BONE SCREWS
K843554 · KTW
Mecron Medical Products, Inc.
Orthopedic · 21d
Cleared Oct 01, 1984
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · JWX
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Oct 01, 1984
RIM-UREA
K843571 · JSS
Austin Biological Laboratories
Microbiology · 20d
Cleared Oct 01, 1984
FETAL BOVINE SERUM, F4884 STERILE GROWT
K843629 · KIS
Sigma Chemical Co.
Pathology · 17d
Cleared Oct 01, 1984
TOTAL PROTEIN REAGENT SET
K843701 · CEK
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Sep 28, 1984
H.P.T. HOME PREG. TEST KIT & A.P.T.
K834474 · LCX
Biomedical Research & Development...
Chemistry · 283d
Cleared Sep 28, 1984
ISO-SEP SYSTEM
K842018 · CEX
Berwick Medical Products, Inc.
Chemistry · 133d
Cleared Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
K842755 · CGS
Helena Laboratories
Chemistry · 74d
Cleared Sep 28, 1984
GLUCOSE AUTO& STAT GA-1120
K843003 · CGA
Kyoto Diagnostics, Inc.
Toxicology · 60d
Cleared Sep 28, 1984
ENZYMATIC CHOLESTEROL KIT
K843222 · CHH
Livonia Diagnostics, Inc.
Chemistry · 43d
Cleared Sep 28, 1984
CREATININE ASSAY KIT
K843377 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 28, 1984
VMA ASSAY KIT
K843379 · CDF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 28, 1984
LEECO CORTISOL-QUANT
K843384 · CGR
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Sep 28, 1984
EMIT 700 CONTROL SET B
K843508 · DIF
Syva Co.
Toxicology · 22d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510 · CHH
Abbott Laboratories
Chemistry · 22d
Cleared Sep 28, 1984
GLUCOSE OXIDASE ENZYMATIC REAGENT SET
K843528 · CGA
Livonia Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 28, 1984
PDA GLUCOSE
K843541 · CFR
Abbott Laboratories
Chemistry · 21d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d