10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Footmotion Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO 30 EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Sterile High-pressure Angiographic Syringes for single-use
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2020
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 13, 2023
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·December 11, 2025
ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 3, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 1, 2013
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 23, 2014