8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMBRANDT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SMALL VOLUME SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
13.5CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 13, 2014
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 15, 2013
SIZE 4-8 KEEL PUNCH GUIDE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 22, 2010
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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