10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEM-9210T
FDA 510(k)
FDA Class 2
·Cardiovascular
LINK Instruments - Alignment and positioning instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397716·Orthopaedic prosthesis implantation instrument,...
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 9, 2020
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·September 1, 2016
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 11, 2013
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 8, 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