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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50641–50664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2010
AIRWAYEASE MAS
K090436 · LRK
Orthoplant Dental Lab
Dental · 421d
Cleared Apr 16, 2010
VAPOR-CLEAR, MODEL 100
K092031 · CBN
Axon Medical, Inc.
Anesthesiology · 284d
Cleared Apr 16, 2010
AMERICAN DENTAL PRODUCTS SE BONDEASY
K093014 · KLE
American Dental Products, Inc.
Dental · 199d
Cleared Apr 16, 2010
AMBU ASCOPE AND MONITOR
K093186 · BTR
Ambu A/S
Anesthesiology · 189d
Cleared Apr 16, 2010
SORING MBC200/BCC140
K093511 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 154d
Cleared Apr 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS...
K093780 · NHA
Astra Tech, Inc.
Dental · 128d
Cleared Apr 16, 2010
PEANUT GROWTH CONTROL PLATING SYSTEM
K093880 · HRS
Ebi, L.P.
Orthopedic · 119d
Cleared Apr 16, 2010
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K094018 · HCG
Biocompatibles UK Limited
Neurology · 108d
Cleared Apr 16, 2010
ELI 230 ELECTROCARDIOGRAPH
K100127 · DPS
Mortara Instrument, Inc.
Cardiovascular · 87d
Cleared Apr 16, 2010
GDS-DC12
K100135 · DQY
Guided Delivery Systems
Cardiovascular · 87d
Cleared Apr 16, 2010
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
K100173 · KNT
Sainath Intellectual Properties, LLC
Gastroenterology & Urology · 85d
Cleared Apr 16, 2010
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K100241 · BSP
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · NAJ
Boston Scientific Corporation
Obstetrics & Gynecology · 39d
Cleared Apr 15, 2010
CLARO
K090744 · OLP
Clrs Technology Corporation
General & Plastic Surgery · 391d
Cleared Apr 15, 2010
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198 · KXA
Corin USA
Orthopedic · 268d
Cleared Apr 15, 2010
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES,...
K092472 · LZA
Ascend Eagle, Inc.
General Hospital · 246d
Cleared Apr 15, 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
K093611 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared Apr 15, 2010
ELECSYS TSH CALCHECK 5
K093836 · JJX
Roche Diagnostics
Chemistry · 121d
Cleared Apr 15, 2010
INOMAX DS
K093922 · MRN
Ino Therapeutics
Anesthesiology · 114d
Cleared Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991 · LZO
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared Apr 15, 2010
BD PEN NEEDLE
K100005 · FMI
Becton, Dickinson and Co.
General Hospital · 101d
Cleared Apr 15, 2010
LASERTOUCHONE (OTC)
K100116 · NUH
Laser Health Technologies, LLC
Neurology · 90d
Cleared Apr 15, 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · KWP
Lanx, Inc.
Orthopedic · 83d
Cleared Apr 15, 2010
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
K100394 · MWI
Shanghai 3f Electronics Co, Ltd.
Cardiovascular · 58d