8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RECOVERY PROTRUSIO CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
BEXCORE Breast Biopsy System, Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 21, 2013
THE SPANNER TEMPORARY PROSTATIC STENT
FDA Adverse Event
Other
·ABBEYMOOR MEDICAL INC.·Product code NZC·January 17, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·July 31, 2014
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