9 results
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25ms
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Sources: EU EUDAMED, US FDA
ARTHRO-PREP REST W/STAND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ERA® Implant Abutment Micro 0°, 3mm Cuff (AT)
FDA UDI
STERNGOLD DENTAL LLC·00841549103506·ERA abutments provide a resilient attachment wi...
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REALSEAL
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·May 15, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·August 17, 2010
TORQUE LIMITING ATTACHMENT 1.2NM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code LXH·June 4, 2015
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