10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QEA SODIUM/POTASSIUM ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ihcDirect® E-Cadherin Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596627·Clone R1005
ihcDirect® E-Cadherin Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596917·Clone R1005
ihcDirect® E-Cadherin Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934871·Clone R1005
GEMINI 16
FDA 510(k)
FDA Class 2
·Radiology
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
FDA 510(k)
FDA Class 2
·Cardiovascular
ARIS TRANS-OBTURATOR
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FTL·February 7, 2014
ADVANIX BILIARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·November 14, 2012
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code EZB·September 13, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024