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
165457–165480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1980
FIGURETRIM
K802269 · IPF
Colne Medical Co. , Ltd.
Physical Medicine · 26d
Cleared Oct 10, 1980
BED ROCKING DEVICE
K801517 · FNJ
Wesler
General Hospital · 101d
Cleared Oct 10, 1980
SERO STREP KIT
K801775 · GTZ
Sacks Farms Biological Products
Microbiology · 74d
Cleared Oct 10, 1980
AUTOLET
K801815 · JCA
Ulster Scientific, Inc.
Hematology · 72d
Cleared Oct 10, 1980
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841 · GHH
American Hospital Supply Corp.
Hematology · 70d
Cleared Oct 10, 1980
S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX
K801860 · EJK
Pennwalt Corp.
Dental · 66d
Cleared Oct 10, 1980
INPERSOL-CAPD ADMINISTRATION SET
K801881 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 64d
Cleared Oct 10, 1980
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
K801884 · FPX
Acme United Corp.
General & Plastic Surgery · 64d
Cleared Oct 10, 1980
GLUCOSE DIAGNOSTIC REAGENT
K801897 · CGA
Connecticut Diagnostics, Ltd.
Chemistry · 63d
Cleared Oct 10, 1980
URIC ACID DIAGNOSTIC REAGENT
K801898 · KNK
Connecticut Diagnostics, Ltd.
Chemistry · 63d
Cleared Oct 10, 1980
ANTI-DS/N-DNA TEST KIT
K801960 · DBL
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 10, 1980
RF-II TEST KIT
K801961 · DHR
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 10, 1980
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI
K801964 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Oct 10, 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Oct 10, 1980
DRESSING CHANGE SET CAT.#910-930
K802017 · KDD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 51d
Cleared Oct 10, 1980
VIALON SURGEON'S GLOVES
K802027 · KGO
Rivefain Corp.
General Hospital · 50d
Cleared Oct 10, 1980
CO2 MICROSURGICAL LASER SYSTEM #370
K802034 · EWG
Metricon, Ltd.
Ear, Nose, Throat · 49d
Cleared Oct 10, 1980
STERILE TONSIL SPONGES
K802060 · GDY
Medspec Corp.
General & Plastic Surgery · 46d
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · JJX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Oct 10, 1980
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · JFS
J.T. Baker Chemical Co.
Chemistry · 43d
Cleared Oct 10, 1980
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
K802091 · JGJ
American Monitor Corp.
Chemistry · 38d
Cleared Oct 10, 1980
ORTHO SPECTRUM
K802094 · GKL
Ortho Instruments
Hematology · 38d
Cleared Oct 10, 1980
GORE-TEX VASCULAR GRAFT
K802095 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 38d
Cleared Oct 10, 1980
SELF-RECORDING ADMITTANCE METER 709
K802097 · ETY
Amplaid USA, Inc.
Ear, Nose, Throat · 38d