7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASSALLO GT 018 Floppy
FDA 510(k)
FDA Class 2
·Cardiovascular
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Foundation Dermal Regeneration Scaffold (DRS) Solo
FDA 510(k)
FDA Unclassified
·Unknown
ULTIMA CALCAR STD LGT, SZ4 55MM
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JDI·October 27, 2008
PFC SIGMA TC3 FEM LEFT SZ3
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 12, 2011
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019