15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straub Endovascular System
FDA 510(k)
FDA Class 2
·Cardiovascular
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804038·Castroviejo Needle Holder, Curved, Flat Handle ...
PIN SCREW
FDA UDI
BK MEDITECH CO.,LTD.·08809155854214·Cortical Pin Screw, 3mm Shaft Diameter x 2.3mm ...
STAXX XDL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS REX CURVED BUR
FDA 510(k)
FDA Class 2
·Neurology
INTERCHANGEABLE ULNAR ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·April 24, 2013
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·October 15, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 19, 2008
INTERCHANGEABLE HUMERAL ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·June 13, 2017
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·August 12, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·August 12, 2019
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 12, 2019
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