13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Glenoid Polyaxial Non-locking Screws
FDA 510(k)
FDA Class 2
·Orthopedic
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021
Origin 125º Short Neck Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215024192·
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 9, 2025
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
AUTOLUBE III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 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