2,860 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CLAYTON INTRA-AURAL DEVICE (CID)
FDA 510(k)
FDA Unclassified
·Unknown
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 1, 2008
WALLSTENT-UNI¿ ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 4, 2011
SCRDRIVERSHAFT T25 F/URS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 27, 2013
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 13, 2026
IMP,TSV,MCOL MG,6.0MM,11MM,MTX
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 18, 2026
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 30, 2026
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 15, 2022
IMP,TSV,6.0,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 26, 2020
IMP,TSV,MCOL MG,4.7MM,8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·August 4, 2022
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 18, 2026
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026
IMP,TSV,6.0,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 12, 2021
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 16, 2026
IMP,TSV,6.0,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 28, 2026
IMP,TSV,MCOL MG,4.7MM,8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 20, 2026