BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEADWAY DUO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756003643·Knee Immobilizer

    ArgenPMMA Multi 98x14-C3

    FDA UDI
    ARGEN CORPORATION, THE·D818120917·Crown And Bridge, Temporary, Resin

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756962605·KNEE IMMOBILIZER

    FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·October 23, 2017

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·July 13, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013

    PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP*

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·September 26, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 12, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·September 10, 2019

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·June 12, 2014

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·January 30, 2013

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013