11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pac-Dent Denture Base Resin
FDA 510(k)
FDA Class 2
·Dental
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706657·Aufricht Nasal Retractor 7" (17.5cm), 10mm blade
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450387245·
REPROCESSED ELECTROSURGICAL INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VORTEX ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 20, 2008
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
FDA Enforcement
Class II
·Terminated·Myco Medical Supplies Inc·March 6, 2013
TRUE METRIX PRO
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·February 13, 2023
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