10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
NOVAMETRIX PHYSIOLOGICAL MONITOR #910
FDA 510(k)
FDA Class 2
·Cardiovascular
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2020
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·August 5, 2020
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 18, 2010
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 28, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024