9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ManaSport+
FDA 510(k)
FDA Class 2
·Physical Medicine
Bernafon
FDA UDI
Bernafon AG·05714464006960·AO9 MNR T R SABE/MAC DEMO ALIGO 9 GPL
GLOBAL UNITE Platform Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
APPS-HEALTH01
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
GDC-10 360 COIL
FDA Adverse Event
Injury
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·November 5, 2008
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 24, 2011
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 2, 2013
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