11 results · 22ms · Sources: EU EUDAMED, US FDA

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CONQUEST FN

FDA 510(k)
FDA Class 2 ·Orthopedic

SAIPH

FDA UDI
MATORTHO LTD·05055455506114·SAIPH Femur Cemented Blue Right Size 5

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

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2024

MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 5, 2011

PREFYX PPS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·June 27, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 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