10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODUS SAGITTAL SPLIT PLATE
FDA 510(k)
FDA Class 2
·Dental
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 1, 2018
CAREVENT HANDHELD CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
FLEXGARD SYRINGE PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·March 1, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 11, 2011
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 1, 2018
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 1, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024