7 results
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18ms
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Sources: EU EUDAMED, US FDA
DERATA MEDI-JECTOR V
FDA 510(k)
FDA Class 2
·General Hospital
RIONET HEARING AID HB-69CI
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MARVEL PEDIATRIC WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
THERMOPHORE AUTOMATIC HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT·Product code IRT·June 13, 2014
MP70 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code DSI·October 22, 2010
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·December 21, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024