11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lumify Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TARGETING ARM PROX. LAT TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482037782·Symmetry® Retractor, Contour Scalp, Blunt, 5 1/...
FUTURABOND NR
FDA 510(k)
FDA Class 2
·Dental
Vericore Zirconia Blanks
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·November 11, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013
IMP,TSV,MCOL MG,4.1MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 13, 2022
IMP,TSV,MCOL MG,4.1MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 21, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025