20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOLOC® 3Di Ankle Fracture Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011630440·
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARDIOBELT ELECTRODE BELT
FDA 510(k)
FDA Class 2
·Cardiovascular
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·September 12, 2008
UNK BACTISEAL CATHETER
FDA Adverse Event
Injury
·Product code JXG·March 24, 2017
UNK HAKIM PRECISION VALVE
FDA Adverse Event
Injury
·Product code JXG·March 24, 2017
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2017
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 9, 2024
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·December 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·December 2, 2020
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 19, 2020
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 19, 2020
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