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
154897–154920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1983
LUMEN-4 URODYNAMIC CATHETER
K833628 · FAP
Surgitek
Gastroenterology & Urology · 45d
Cleared Nov 28, 1983
THERMAMED BATH
K833631 · IMC
Bernlit Enterprises, Inc.
Physical Medicine · 42d
Cleared Nov 28, 1983
D-LYTE
K833653 · KOC
Dialysis Products, Inc.
Gastroenterology & Urology · 39d
Cleared Nov 28, 1983
PRESERV PVA FIXATIVE -MALIN PACK
K833660 · KDT
Preventive Diagnostics Corp.
Microbiology · 41d
Cleared Nov 28, 1983
ELECTROCARDIOCORDER RECORDER 453
K833661 · DSH
Del Mar Avionics
Cardiovascular · 41d
Cleared Nov 28, 1983
PRIMARY PIGGYBACK INFUSION SET W/PERM
K833682 · LDR
Cosmetic Sciences, Inc.
General Hospital · 28d
Cleared Nov 28, 1983
GENTLE FLOW BREAST PUMP
K833835 · HGY
Eklund & Co.
Obstetrics & Gynecology · 25d
Cleared Nov 28, 1983
IPOS G.L.P. SYSTEM
K833868 · KFX
Ipos Luneburg
Physical Medicine · 21d
Cleared Nov 25, 1983
ELASTOPLAST
K831438 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 204d
Cleared Nov 25, 1983
POLYSTYRENE MICROTITER WELL IMMUNOSOR
K832345 · DGC
Diagnostic Reagent Tech.
Immunology · 130d
Cleared Nov 25, 1983
EVOKED POTENTIALS SYSTEM MK10
K832510 · GWJ
Amplaid USA, Inc.
Neurology · 121d
Cleared Nov 25, 1983
DUPONT LINEARIZATION MODULE
K832746 · JQP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 102d
Cleared Nov 25, 1983
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795 · HCH
Edward Weck, Inc.
Neurology · 99d
Cleared Nov 25, 1983
AMYLASE
K832889 · JFJ
Pointe Scientific, Inc.,
Chemistry · 95d
Cleared Nov 25, 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · CAF
Siemens Elema AB
Anesthesiology · 91d
Cleared Nov 25, 1983
SERVO HEATED RESPIRATORY HUMIDIFIER
K832928 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 93d
Cleared Nov 25, 1983
GOLD FILM MERCURY ANALYZER #511
K832933 · DPH
Jerome Instrument Corp.
Chemistry · 87d
Cleared Nov 25, 1983
BX-600 EMS
K832976 · IPF
Bloomex International, Inc.
Physical Medicine · 84d
Cleared Nov 25, 1983
SERUM CHOLINESTERASE REAGENT SET
K833062 · DLI
Sterling Biochemical, Inc.
Chemistry · 78d
Cleared Nov 25, 1983
REAGENT SET TRIGLYCERIDES GPO
K833082 · CDT
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Nov 25, 1983
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
K833153 · JJF
Nova Biomedical Corp.
Chemistry · 71d
Cleared Nov 25, 1983
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K833156 · JHJ
Quidel Corp.
Chemistry · 70d
Cleared Nov 25, 1983
POTASSIUM ELECTRODE TIP ASSAMBLY-K-
K833159 · CEM
Hi Chem, Inc.
Chemistry · 70d
Cleared Nov 25, 1983
TOOTH SLOOTH
K833338 · EJB
Joel Lander D.D.S.
Dental · 59d