9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Active Breathing Coordinator
FDA 510(k)
FDA Class 2
·Radiology
CALGAESEAL MODEL: CAS
FDA 510(k)
FDA Unclassified
·Unknown
GERATHERM SOS-RESCUE BLANKET
FDA 510(k)
FDA Class 2
·Cardiovascular
BELLAFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·July 12, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
HUDSON HEATED-WIRE VENTILATOR CIRCUIT W/LIMB
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·June 20, 2011
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 8, 2014
DM ACETABULAR LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 18, 2015
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016