7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
HCG-CHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IQMARK DIGITAL HOLTER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAPCHECK2, ARCCHECK
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ASR XL ANATOMIC HEAD SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
NOT APPLICABLE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·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