14 results · 19ms · Sources: EU EUDAMED, 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