BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Reprocessed Polaris X Steerable Diagnostic EP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035965·2.0/2.4mm Cannulated Headless Driver, Long

    Rumex

    FDA UDI
    RUMEX INTERNATIONAL CORP.·00840159905494·Corneal Trephine Blades, 7.00 mm, Stainless Steel

    VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    STRATUS CS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015

    STRATUS CS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·April 29, 2011

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVZ·April 27, 2018

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016