BEUDAMED
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    RANDOX TRANSFERRIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019348·Endo Carry-On Procedure Kit

    NA

    FDA UDI
    Ge Medical Systems Information Technologies, Inc.·00840682119030·SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYST...

    G-CEM™

    FDA UDI
    Gc America Inc.·14548161293495·G-CEM™ AO3, box of 50 capsules

    G-CEM™

    FDA UDI
    Gc America Inc.·D0470025851·G-CEM™ AO3, box of 50 capsules

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009320·PedFuse, Rod, Straight, Bulleted, 5.5mm X 85mm

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 13, 2014

    ULTRASOUND SCANNER, TYPE 1101

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981116927·8.5 Cannulated Tap

    ZPower Rechargeable System for Hearing Aids

    FDA UDI
    ZPOWER, LLC·00850034007502·Charger for ZPower Rechargeable System for Hear...

    M2A 38MM MOD HD+9MM NK NO SKRT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·December 13, 2012

    M2A 38MMX60MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·December 13, 2012

    ITOTAL TIBIAL IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS, INC.·Product code LXH·February 13, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011

    IAB : 8 FR 30 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·February 8, 2008

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024