12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MR4 Laser
FDA 510(k)
FDA Class 2
·Physical Medicine
SR PIP
FDA UDI
Stryker GmbH·00886385020075·SR PIP INSTRUMENT SET, DISTAL IMPACTOR
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 14, 2023
FETCH 2 ASPIRATION CATHETER MODEL 109400-001
FDA 510(k)
FDA Class 2
·Cardiovascular
MEPILEX AG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·June 14, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 18, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
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