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

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    TRACE MAGNESIUM - ARSENAZO REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VARILIFT -C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

    FDA 510(k)
    FDA Class 2 ·Immunology

    5MM HEX FLEXIBLE SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·April 15, 2020

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 17, 2013

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MTA·October 28, 2010

    ANTHEM RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021