20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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