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

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    ACUFEX PASSING PINS AND SURGICAL WIRE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    16PW - Consolidated Comm - Plant

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588206219·Consolidated Comm - Plant - 16 Poly White

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP

    ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NASAL INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    HEARTMATE II LVAS

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

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 13, 2010

    ASSURITY DR RF

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

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015