9 results
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19ms
·
Sources: EU EUDAMED, US FDA
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
FDA 510(k)
FDA Class 2
·Hematology
Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746189302·WELD TUBE INCONEL Ø 040 4.5MM 100/PK
Tubing
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746146534·TUBE 040 4.5MM 100/PKG
Foresight Intracardiac Echocardiography (ICE) System
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOSCOPE SONOPLUS 3000
FDA 510(k)
FDA Class 2
·Cardiovascular
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 22, 2014
MARYLAND BIPOLAR FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
DELTA CER HEAD 12/14 36MM +1.5
FDA Adverse Event
Injury
·DEPUY (IRELAND) 9616671·Product code MRA·June 17, 2015
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