9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Duatene bilayer mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 23, 2019
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DISCOVERY RF180
FDA Adverse Event
Injury
·GENERAL MEDICAL MERATE S.P.A.·Product code JAA·August 2, 2023
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·October 15, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·July 22, 2011
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 17, 2013
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