10 results · 19ms · Sources: EU EUDAMED, US FDA

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CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)

FDA 510(k)
FDA Class 2 ·Neurology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450217412·

Phototherapy System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SYNGO MULTIMODALITY WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

ASR XL TAP SLV ADAP 12/14+5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·January 11, 2013

PROFEMUR(R) MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·November 30, 2010

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 2, 2014

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

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