12 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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Medline UNITE® Snap-Off Screws
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074124·Cone Retractor
3x4 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418140·Cone Retractor 3x4 teeth 24cm blunt
with j...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418133·Cone Retractor 3x4 teeth 215mm blunt
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418119·Cone Retractor 3x4 teeth 13cm blunt
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XVAC
FDA 510(k)
FDA Class 2
·Anesthesiology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·June 22, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
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