14 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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Digital Diagnostic X-ray System (GC80)
FDA 510(k)
FDA Class 2
·Radiology
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828177481·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828179805·GEN4 INTERACTIVE
LEONE SPA
FDA UDI
LEONE SPA·08033707011873·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 29
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNGO VIA MI WORKFLOWS
FDA 510(k)
FDA Class 2
·Radiology
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
IDENTITY ADX SR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 3, 2013
ISOMED NON-PROGRAMMABLE PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011
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