8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MONITOR, BED, TECHNOLICS
FDA 510(k)
FDA Class 1
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515200135·Humeral Head retractor,forked blunt prongs, str...
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
VenaCure EVLT NeverTouch Direct Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
PROMUS PREMIER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 24, 2014
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2007
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 1, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022