11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PNEUMOCLEAR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418164·House Retractor with hinge, 16.5cm,
right ...
INION BIORESTORE
FDA 510(k)
FDA Class 2
·Dental
UC-CARE NAVIGO SYTEM
FDA 510(k)
FDA Class 2
·Radiology
MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA Adverse Event
Malfunction
·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 22, 2011
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
ASAHI GLADIUS MG14 PV ES
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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