12 results · 21ms · Sources: EU EUDAMED, 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