11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SERAQUEST CMV IGG
FDA 510(k)
FDA Class 2
·Microbiology
TriVerse X-Ray Digital Template, Tibial I-Beam
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215114312·
MECRON UNCEMENTED STRUCTURED STEM HIP
FDA 510(k)IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·February 11, 2013
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 10, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 23, 2014
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014