7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
IDENTOFLEX
FDA 510(k)
FDA Class 1
·Dental
EPTONE BACK-UP BROTH, VACUTAINER
FDA 510(k)
FDA Class 1
·Microbiology
EXERCISER, LEG, LOWER EXTREMITY
FDA 510(k)
FDA Class 1
·Physical Medicine
TRI-LOCK BPS SZ 4 STD OFFSET
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code KWA·April 24, 2014
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·October 4, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024