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
139633–139656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · CIG
American Research Products Co.
Chemistry · 28d
Cleared May 18, 1987
ANESTHASSIST
K871564 · BRY
Anestech, Inc.
Anesthesiology · 26d
Cleared May 18, 1987
ORMCO GEL-ETCH
K871591 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared May 18, 1987
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
K871611 · HKO
Allergan Humphrey
Ophthalmic · 38d
Cleared May 18, 1987
DENTAL DIAMOND BURS
K871639 · DZP
E&D Dental Manufacturing Co.
Dental · 21d
Cleared May 18, 1987
TANNE CORNEAL CUTTING BLOCK
K871646 · HNJ
Ocular Instruments, Inc.
Ophthalmic · 20d
Cleared May 18, 1987
ENZYMATIC CHOLESTEROL REAGENT SET
K871676 · CHH
Michclone Associates, Inc.
Chemistry · 20d
Cleared May 18, 1987
OPTHA PREP
K871706 · HMT
Treace Medical, Inc.
General Hospital · 17d
Cleared May 18, 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · FKO
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared May 15, 1987
GASTROTOPO
K861291 · FGE
Houston Biomedical, Inc.
Gastroenterology & Urology · 403d
Cleared May 15, 1987
AEROSOL ONE, NEBULIZER PUMP
K870428 · BTI
Ashai Co. , Ltd.
Anesthesiology · 101d
Cleared May 15, 1987
PRECIMAT(R) C3
K871024 · CZW
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
PRECINORM(R) PROTEIN
K871027 · DAF
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared May 15, 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared May 15, 1987
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K871066 · CAZ
The Kendal Co.
Anesthesiology · 59d
Cleared May 15, 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · KDI
Gambro, Inc.
Gastroenterology & Urology · 57d
Cleared May 15, 1987
THE SPIRA ELEKTRO 2
K871151 · CCQ
Warren E. Collins, Inc.
Anesthesiology · 53d
Cleared May 15, 1987
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
K871193 · JZO
Cronus
Immunology · 52d
Cleared May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · JQP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · CFN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
CELL LIFTER
K871559 · LIB
Corning Costar Corp.
Microbiology · 23d
Cleared May 15, 1987
SPOTTEST FLAGELLA STAIN
K871606 · JTS
Difco Laboratories, Inc.
Pathology · 21d
Cleared May 15, 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · JTN
Organon Teknika Corp.
Microbiology · 16d