51 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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qER
FDA 510(k)
FDA Class 2
·Radiology
CORTRAK* Enteral Access System
FDA UDI
Avanos Medical, Inc.·00350770456287·Mounting Adapter Kit
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776345518·Spinal Fusion Curette, size 0000
BAYER ADVIA IMS SYSTEM; 200 + 3
FDA 510(k)
FDA Class 2
·Immunology
NO-POKES NEEDLE SAFETY DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 15, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
SHILEY DISPOSABLE CANNULA LOW PRESSURE
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·April 20, 2010
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 11, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code FPA·July 2, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 24, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 2, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 4, 2012
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 21, 2016
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·February 18, 2010
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2025
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 22, 2010