11 results
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18ms
·
Sources: EU EUDAMED, US FDA
ALPHA CHUCK
FDA 510(k)
FDA Class 1
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128280·
MICRO-STRUCTURED HS2P HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Wovyn Depth Electrode
FDA 510(k)
FDA Class 2
·Neurology
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GEY·April 17, 2014
PULSAR MAX II
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·October 5, 2010
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FRN·October 24, 2012
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·December 7, 2020
DRIVING CAP F/INSERTION HANDLE
FDA Adverse Event
Malfunction
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code LXH·January 4, 2018
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026