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
54553–54576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2009
A.V. FISTULA BLUNT NEEDLE SET
K082882 · FIE
Jms North America Corp.
Gastroenterology & Urology · 113d
Cleared Jan 21, 2009
COSTORSOL
K083453 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 61d
Cleared Jan 21, 2009
IBOND TOTAL ETCH
K083652 · KLE
Heraeus Kulzer,GmbH
Dental · 43d
Cleared Jan 21, 2009
CYNOSURE SMARTLIPO MPX LASER
K083795 · GEX
Cynosure, Inc.
General & Plastic Surgery · 30d
Cleared Jan 21, 2009
UNIVERSAL ELECTRODES
K083818 · GXY
Neurometrix, Inc.
Neurology · 30d
Cleared Jan 16, 2009
EPIVISION SL SYSTEM
K072102 · HNO
Gebauer Medizintechnik GmbH
Ophthalmic · 535d
Cleared Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · CIG
Roche Diagnostics
Chemistry · 263d
Cleared Jan 16, 2009
OMNILUX CLEAR-U
K081307 · OLP
Photo Therapeutics, Inc.
General & Plastic Surgery · 253d
Cleared Jan 16, 2009
HEALTH MANAGER, VERSION 1.1
K081499 · DRG
Biocomfort Diagnostics GmbH & Co. KG
Cardiovascular · 232d
Cleared Jan 16, 2009
COULTER LIN-X LINEARITY CONTROL
K081641 · JPK
Beckman Coulter, Inc.
Hematology · 219d
Cleared Jan 16, 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · JJW
Cliniqa Corporation
Chemistry · 197d
Cleared Jan 16, 2009
MEDIGARD BLOOD COLLECTION DEVICE
K082511 · FMI
Medigard Limited
General Hospital · 140d
Cleared Jan 16, 2009
DUAL NEEDLE SUTURE PASSER SYSTEM
K082518 · GAT
Cayenne Medical, Inc.
General & Plastic Surgery · 136d
Cleared Jan 16, 2009
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
K082521 · NBW
Card Guard Scientific Survival , Ltd.
Chemistry · 136d
Cleared Jan 16, 2009
PAM 3000
K082626 · DRT
Wireless 2000 RF & Uwb Technologies ,...
Cardiovascular · 129d
Cleared Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Jan 16, 2009
PM-1000F+PATIENT MONITOR
K082887 · MWI
Advanced Instrumentations, Inc.
Cardiovascular · 108d
Cleared Jan 16, 2009
FORA TELEHEALTH SYSTEM
K083046 · DRG
Taidoc Technology Corporation
Cardiovascular · 94d
Cleared Jan 16, 2009
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
K083099 · NBW
Eps Bio Technology Corp.
Chemistry · 88d
Cleared Jan 16, 2009
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
K083194 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 79d
Cleared Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
K083387 · HKI
Kowa Co. , Ltd.
Ophthalmic · 60d
Cleared Jan 16, 2009
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60,...
K083517 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 51d
Cleared Jan 16, 2009
NASO-LARYNGO-PHARYNGOSCOPE
K083553 · EOB
Schoelly Imaging, Inc.
Ear, Nose, Throat · 46d
Cleared Jan 16, 2009
NORAS CPC MULTIFUNCTIONAL COIL
K083578 · MOS
Noras Mri Products GmbH
Radiology · 44d