20 results · 23ms · Sources: EU EUDAMED, US FDA

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NHAC 16

FDA 510(k)
FDA Class 2 ·Radiology

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK115151·DD tempMED are pre-colored dental milling blank...

SR MCP

FDA UDI
Stryker GmbH·00886385020853·S.R. MCP METACARPAL BROACH, SIZE XS

SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019

ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM

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

SPSMEDICAL SPORVIEW STEAM BI

FDA 510(k)
FDA Class 2 ·General Hospital

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

PROVISC

FDA Adverse Event
Malfunction ·ALCON - BELGIUM / S.A. ALCON-COUVRUER N.V.·Product code LZP·September 17, 2008

STANDARD MICRO INTRODUCER KIT

FDA Adverse Event
Death ·ANGIODYNAMICS·Product code DQX·June 17, 2011

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·October 8, 2020

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·June 15, 2021

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·Product code DQX·October 28, 2021

LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·February 1, 2022

SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Death ·WILLIAM COOK EUROPE·Product code DQX·March 23, 2022

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019

UNKNOWN

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·December 4, 2019

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Death ·WILLIAM COOK EUROPE·Product code DQX·July 18, 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