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

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DePuy Actis Duofox Hip Prosthesis

FDA 510(k)
FDA Class 2 ·Orthopedic

HHM

FDA UDI
Oticon A/S·05707131282262·H160V2 TI, BTE 13 WL 85 DBL HHM

BIOMET PATELLAR SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304207981·

Biomet® Patellar System

FDA UDI
Biomet Orthopedics, LLC·00887868344411·

3TP WORKSPACE

FDA 510(k)
FDA Class 2 ·Radiology

BODYFLOW P2CH

FDA 510(k)
FDA Class 2 ·Physical Medicine

INCEPTA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013

HIP HEAD,10/12 TAPER,28MM,+0MM

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 29, 2011

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

SENRI

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code DQY·December 25, 2016

METACROSS RX PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·October 15, 2019

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