10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUFEX METAL ACL CANNULA
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 6, 2024
EMIT CAD PROCAINAMIDE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTEGRITY SPINE CORE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOPATH** XCEL* STABILITY SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·January 29, 2013
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Death
·SPECTRANETICS CORP.·Product code MFA·December 2, 2010
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code LPH·July 14, 2014
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
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015