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
144121–144144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1986
TSHK-NN RIA KIT
K860824 · JLW
Cis-Us, Inc.
Chemistry · 55d
Cleared Apr 28, 1986
GUIDE WIRE INTRODUCER
K860841 · DQX
Target Therapeutics
Cardiovascular · 55d
Cleared Apr 28, 1986
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · CGI
Sclavo, Inc.
Chemistry · 49d
Cleared Apr 28, 1986
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K861025 · KDQ
Boehringer Laboratories
General Hospital · 41d
Cleared Apr 28, 1986
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
K861104 · BYE
Med Air Technology, Inc.
Anesthesiology · 35d
Cleared Apr 28, 1986
MULTI-SPIKE
K861203 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 27d
Cleared Apr 28, 1986
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231 · CKA
Hi Chem, Inc.
Chemistry · 27d
Cleared Apr 28, 1986
AST REAGENT CARTRIDGE
K861283 · CIT
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
AP REAGENT CARTRIDGE
K861284 · CJE
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
ULTRA-VIOLET GOGGLETS
K861333
Health Saver Products
Ophthalmic · 19d
Cleared Apr 28, 1986
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419 · CFJ
Hi Chem, Inc.
Chemistry · 13d
Cleared Apr 28, 1986
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID
K861448 · JJY
Quantimetrix Medical Industries
Chemistry · 47d
Cleared Apr 25, 1986
DB PRECISION IMPLANT SYSTEM, 2000 SERIES
K860982 · DZE
Driskell Bioengineering
Dental · 39d
Cleared Apr 25, 1986
P.O. VOX
K860993 · ESE
Bloomfield Research and Development,...
Ear, Nose, Throat · 39d
Cleared Apr 25, 1986
GLASIONOMER BASE CEMENT
K861005 · EMA
Shofu Dental Corp.
Dental · 38d
Cleared Apr 25, 1986
TAN MATE HOME TANNING UNIT
K861107 · FTC
Specialty Engineering, Inc.
General & Plastic Surgery · 32d
Cleared Apr 25, 1986
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K861167 · CZP
Atlantic Antibodies
Immunology · 28d
Cleared Apr 25, 1986
QUIDEL ALLERGY SCREEN
K861171 · DGC
Quidel Corp.
Immunology · 28d
Cleared Apr 25, 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184 · DHB
Pharmacia, Inc.
Immunology · 25d
Cleared Apr 25, 1986
MONITRAL S
K861230 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 24d
Cleared Apr 25, 1986
IAP PLATE TEST
K861336 · LKL
Scientific Sales Intl., Inc.
Immunology · 16d
Cleared Apr 25, 1986
REPLACEMENT HOSES
K861405 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 10d
Cleared Apr 24, 1986
AEROSOL ONE
K852622 · BTI
Ashai Co. , Ltd.
Anesthesiology · 308d
Cleared Apr 24, 1986
EBV(EPSTEIN-BARR VIRUS) TEST KIT
K854207 · GNP
Immuno-Diagnostic Products, Inc.
Microbiology · 190d