Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156793–156816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
AMERI CLEAR
K832011 · KEM
Stephens Scientific
Hematology · 50d
Cleared Aug 12, 1983
LME TEMP. MONITOR
K832042 · FLL
Litton Medical Electronics
General Hospital · 49d
Cleared Aug 12, 1983
RIM-HAEMOPHILUS 1 & 2
K832051 · JST
Austin Biological Laboratories
Microbiology · 49d
Cleared Aug 12, 1983
AMRESCO NA/K REAGENT SET
K832070 · JGS
American Research Products Co.
Chemistry · 46d
Cleared Aug 12, 1983
ELECTRIC INSTRUMENT TABLE
K832073 · HMF
CooperVision, Inc.
Ophthalmic · 45d
Cleared Aug 12, 1983
ELECTRONIC BLOOD PRESS. METER-ZH-820P
K832075 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 45d
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