7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MINICAPS
FDA 510(k)
FDA Class 1
·Hematology
Mammo Workstation
FDA 510(k)
FDA Class 2
·Radiology
ACCUHEART ELECTRODE BELT
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014
STENOSCOPE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·September 22, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024