11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUMBAR IMPACTION SET
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-LOGIC BANKER
FDA 510(k)
FDA Class 2
·Neurology
CENTRICELL(TM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 30, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 30, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 30, 2024
ENDURON NEUT 52OD X 26ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code LPH·June 16, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
MITEK GRYPHON DRILL BIT
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·December 17, 2012
1.25MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LRN·June 21, 2021
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019