7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JMS HALO APPLICATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
FDA 510(k)
FDA Class 2
·Cardiovascular
CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 6, 2010
MEDTRONIC.SIGMA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·December 10, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024