BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162290·Channels Flex Gutta Percha Points 50.06

    PharmGuard

    FDA UDI
    ICU MEDICAL, INC.·15019517225495·

    PharmGuard

    FDA UDI
    ICU MEDICAL, INC.·15019517225471·

    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCANDINAVIAN IVF SCIENCES AB, G1.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025

    THERMAL LIGATING SHEARS

    FDA Adverse Event
    Other ·MICROLINE SURGICAL INC.·Product code GEI·March 20, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 10, 2011

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·March 28, 2008

    IMPELLA 5.5

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·June 21, 2025

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012