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
169105–169128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1979
GLUCOSE (HK) REAGENT
K790786 · CFR
Gilford Diagnostics
Chemistry · 53d
Cleared Jun 15, 1979
ELECTROPHORESIS REAGENT SET, HDL
K790791 · LBT
Gelman Sciences, Inc.
Chemistry · 52d
Cleared Jun 15, 1979
CENTRIA T4 RIA TEST SET
K790800 · CDX
Ventrex Laboratories, Inc.
Toxicology · 52d
Cleared Jun 15, 1979
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST
K790831 · GTQ
Icl Scientific
Microbiology · 46d
Cleared Jun 15, 1979
14 KARAT CASTING GOLD
K790866 · EJT
Williams Gold Refining Co., Inc.
Dental · 39d
Cleared Jun 15, 1979
QUAD IV CUSTOM IMPRESSION TRAY
K790897 · EBH
Sted, Inc.
Dental · 37d
Cleared Jun 15, 1979
NUCLEAR SAMPLE READER
K790905 · JJJ
Abbott Laboratories
Toxicology · 35d
Cleared Jun 15, 1979
EMIT AUTO DIGOXIN ASSAY
K790937 · KXT
Syva Co.
Toxicology · 28d
Cleared Jun 15, 1979
HISTO-OILER
K790956 · JTC
Dynatech Laboratories, Inc.
Microbiology · 24d
Cleared Jun 15, 1979
HISTO-DISPENSER
K790957 · JTC
Dynatech Laboratories, Inc.
Microbiology · 24d
Cleared Jun 15, 1979
LO-ION
K790973 · KSG
Gamma Biologicals, Inc.
Hematology · 23d
Cleared Jun 15, 1979
MUSCLE TESTING GUN
K791021 · HRW
The Orthodyn Co.
Neurology · 16d
Cleared Jun 15, 1979
CARDIAC CATHETERIZATION SHEETS/PACKS
K791032 · KKX
Surgikos, Inc.
General Hospital · 11d
Cleared Jun 15, 1979
PIGGYBACK BREATHING CIRCUIT
K791034 · BZO
Vital Signs, Inc.
Anesthesiology · 10d
Cleared Jun 15, 1979
CENTRIA T3 UPTAKE TEST SET
K791050
Ventrex Laboratories, Inc.
Toxicology · 9d
Cleared Jun 15, 1979
RAIN-X
K791060 · BZO
Sherwood Medical Co.
Anesthesiology · 7d
Cleared Jun 15, 1979
LIBCO 1,2,3, EYEGLASS FRAMES
K791112 · HQZ
Libco Eyewear, Inc.
Ophthalmic
Cleared Jun 13, 1979
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
K790464 · GLZ
Intl. Diagnostic Technology
Microbiology · 100d
Cleared Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
K790938 · DWP
Shiley, Inc.
Cardiovascular · 26d
Cleared Jun 13, 1979
VOLUREX TM
K791015 · BWF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 12d
Cleared Jun 13, 1979
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
K791042 · CAF
Airlife, Inc.
Anesthesiology · 8d
Cleared Jun 13, 1979
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · CAW
Union Carbide Corp.
Anesthesiology · 8d
Cleared Jun 13, 1979
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
K791044 · BTO
Extracorporeal Medical Specialities,...
Anesthesiology · 8d
Cleared Jun 13, 1979
MODEL GV-10 LANZ PRESSURE-VALVE
K791045 · BTR
Extracorporeal Medical Specialities,...
Anesthesiology · 8d