9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNI WARM GEL PACKS
FDA 510(k)
FDA Class 1
·Physical Medicine
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515245198·Chain Sinus Fcps, large
HVGS 9000
FDA 510(k)
FDA Class 2
·Physical Medicine
MICRO-ARTHROSCOPE
FDA 510(k)
FDA Class 2
·Orthopedic
VASO VIEW HEMOPRO
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 23, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 30, 2013
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Injury
·SPECTRANETICS CORP·Product code MFA·December 13, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015