7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FILTRARE TM ALLVENT TM
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 78210A TELEMETRY TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
FULLY THREADED CANCELLOUS SCREW
FDA Adverse Event
Malfunction
·ZIMMER·Product code HWC·April 18, 2014
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·October 12, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024