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
155953–155976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS
K832098 · LAN
Syva Co.
Chemistry · 44d
Cleared Aug 12, 1983
BLOOD TUBING SET
K832103 · KOC
Lee Medical Intl., Inc.
Gastroenterology & Urology · 50d
Cleared Aug 12, 1983
ELECTRODE LEADS 030-267 & 030-268
K832110 · DTB
Telectronics, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
PROMINJET PUMP
K832120 · FRN
Abbott Laboratories
General Hospital · 43d
Cleared Aug 12, 1983
ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED
K832122 · HCC
Fluidotherapy Corp.
Neurology · 43d
Cleared Aug 12, 1983
VENIPUNCTURE VALVE
K832123 · FPA
Abbott Laboratories
General Hospital · 43d
Cleared Aug 12, 1983
CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI
K832124 · DWF
Med-West, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K832126 · BSP
Smith & Nephew, Mpl Division
Anesthesiology · 42d
Cleared Aug 12, 1983
NAUTILUS MONOPLACE HYPERBARIC UNIT
K832127 · CBF
Nautilus Environmedical Systems, Inc.
Anesthesiology · 42d
Cleared Aug 12, 1983
CONVERTORS FLASH STERILIZING TRAY
K832137 · FSM
American Convertors Div., American...
General & Plastic Surgery · 42d
Cleared Aug 12, 1983
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
K832139 · JHY
Hybritech, Inc.
Chemistry · 46d
Cleared Aug 12, 1983
CRYOMEDICS 5000 CRYOPROBES
K832140 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 45d
Cleared Aug 12, 1983
SOPHEIA DIGOXIN EIA KIT
K832163 · DPO
Diagnostic Products Corp.
Chemistry · 38d
Cleared Aug 12, 1983
GAUZE SPONGE X-RAY DETECTABLE-
K832172 · GDY
Sudreca Surgical Dressings, Inc.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
GAUZE SPONGE STERILE
K832173 · EFQ
Sudreca Surgical Dressings, Inc.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
GAUZE SPONGE NON-STERILE
K832174 · EFQ
Sudreca Surgical Dressings, Inc.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
AMPLATZ HEPARIN COATED CATHETER
K832178 · DQY
Cook, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1983
SNO STRIPS STERILE TEARFLOW TEST STRIP
K832181 · KYD
Smith & Nephew, Inc.
Ophthalmic · 37d
Cleared Aug 12, 1983
LYSING REAGENT
K832182 · GGK
Omega Medical Diagnostics
Hematology · 36d
Cleared Aug 12, 1983
OHIO MODEL 922 SPIROMETER
K832185 · BZG
Airco/Ohio Medical Products
Anesthesiology · 37d
Cleared Aug 12, 1983
HALL DRILL/REAMER
K832186 · GET
Amsco Co.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
HALL OSCILLATOR
K832187 · GET
Amsco Co.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
HALL RECIPROCATOR
K832188 · GET
Amsco Co.
General & Plastic Surgery · 37d
Cleared Aug 12, 1983
PRP-1 REVERSED PHASE RESIN
K832197 · DMZ
Hamilton Co.
Toxicology · 36d