9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LMI CHOLANGIOGRAM TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·August 16, 2012
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
FDA 510(k)
FDA Class 2
·Radiology
VANTAGECATH INTRAVASCULAR CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
MALLINKRODT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·August 17, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
EXTRACT-SCREW CONI F/SCR Ø4.5+6.5
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·December 14, 2012
OSVII CATH.9CM W/O ANTECHAMBER
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·September 20, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015