7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CRP-CHECK
FDA 510(k)
FDA Class 2
·Immunology
MODEL 2100 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 14, 2012
DICEA-210G MULTILINGUAL HIGH PERF D
FDA Adverse Event
Malfunction
·NIPRO CORPORATION USD·Product code KDI·September 10, 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