BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609454·ALLEN, STERIS-AMSCO 4.25" DELUXE GEL

    POLYMACON

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·April 10, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 21, 2008

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

    HOSP SS FLEXX METER W/O LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024