8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-ABSORBABLE SURGICAL SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZ TRANSPORT CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BALL RECORDING ELECTRODE/STIMULATION PROBE
FDA 510(k)
FDA Class 2
·Neurology
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·December 6, 2017
ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 24, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 30, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2014
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020