22 results · 32ms · Sources: EU EUDAMED, US FDA

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OPTION ELITE VENA CAVA FILTER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131259783·RIA PRO, BTE 13 WL 85 TC

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

ITI SYNOCTA MESO ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

ALARIS® PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FPA·February 14, 2019

ENDO CLIP III

FDA Adverse Event
Malfunction ·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018

ENDO CLIP

FDA Adverse Event
Malfunction ·DAVIS & GECK CARIBE LTD·Product code FZP·January 24, 2019

VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·June 18, 2013

GOLDENBERG TORP HA/PLAST-PORE

FDA Adverse Event
Injury ·GYRUS ACMI, INC.·Product code ETA·May 24, 2013

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·May 11, 2011

XPAND SPACER SMALL 12X14 3.5/3.5 42-57MME

FDA Adverse Event
Injury ·GLOBUS MEDICAL, INC.·Product code MQP·August 14, 2008

VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·April 27, 2022

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

SCREW,FIXATION,BONE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HWC·December 30, 2014

UNK - SCREWS: 2.7 MM VA LOCKING

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·March 1, 2024

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·July 22, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·October 24, 2015