BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWPICC CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code IKN·October 18, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 9, 2014

    ANTI-REFLEC Y-SET 8"

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code ---·August 17, 2010

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020