16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131346·TiBase SEV 4.8 1.0G E
GC ORAL MOISTURIZING GEL
FDA 510(k)
FDA Unclassified
·Unknown
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDURON 10D 54OD X 28ID
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 1, 2014
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTP·May 17, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012