13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OIC Variable Angle Small Fragment Locking Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
INSIGNIA DIGICAST
FDA 510(k)
FDA Class 2
·Dental
Dakota ALIF System
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 17, 2025
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 7, 2024
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 25, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 12, 2013
THREE PEG PATELLA 41MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 19, 2024
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 3, 2024
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 3, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025