9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
FDA 510(k)
FDA Class 2
·Cardiovascular
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331416·Cortical screw for use with tibial nails
TUTOPLAST DURA
FDA 510(k)
FDA Class 2
·Neurology
DURAFILL FLOW
FDA 510(k)
FDA Class 2
·Dental
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 14, 2013
SENSIA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·December 3, 2010
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 3, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017