10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO: PREMIER PLATINUM HPSA
FDA 510(k)
FDA Class 1
·Microbiology
ZMR®
FDA UDI
Zimmer, Inc.·00889024365100·
ZMR®
FDA UDI
Zimmer, Inc.·00889024365094·
ZMR®
FDA UDI
Zimmer, Inc.·00889024160958·
16CH AI BREAST COILS 1.5 T AND 3 T
FDA 510(k)
FDA Class 2
·Radiology
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
FDA 510(k)
FDA Class 2
·Hematology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 1, 2013
20X12MM DISP TNG LLETZ LOOP
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·February 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015