13 results · 29ms · Sources: EU EUDAMED, US FDA

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T1/T2/T3 TURBINE FAMILY

FDA 510(k)
FDA Class 1 ·Dental

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131319·TiBase BC NP 1.5G E

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450190111·

OSTEO-G BONE VOID FILLER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

IMMULISA DSDNA ANTIBODY ELISA

FDA 510(k)
FDA Class 2 ·Immunology

GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020

GMK-PRIMARY FEMUR PS CEMENTED SIZE 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019

GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017

GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018

PELVICOL 2 X 4 CM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 17, 2013

ALARIS PUMP MODULE SET

FDA Adverse Event
Malfunction ·CAREFUSION CORPORATION·Product code FPA·September 19, 2014

TOPAZ 3

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 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