49 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Latex Surgical Gloves Powder Free
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584115312·CO5 MNR T, 2.4G NFM MAC CAPTO 5 GPL
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
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 31, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 27, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 19, 2026
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 24, 2008
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 8, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 4, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 2, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·July 31, 2025
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·November 10, 2025
ALINITY I TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·July 14, 2025
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 18, 2025
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 13, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·February 9, 2026