BEUDAMED
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    MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054601·Strip Crown Forms

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001308·artVeneer life upper anteriors, BIM, C1

    Scanlan® TIP-GUARD™ instrument protectors - Tinted

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002072·Scanlan® TIP-GUARD™ instrument protectors - Ori...

    Sectum Cable Body Applicator

    FDA UDI
    NEAUVIA NORTH AMERICA, INC.·00850017374164·

    Rampart One Lumbar Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7401001308·Trial 10.5mm S 8°

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179482·

    AC20,BASE MODULE,36",RAULAND R5

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828179874·AC20,BASE MODULE,36",RAULAND R5

    WALLSTENT BILIARY ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LINER: MPACT FLAT PE HC LINER 36/G

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 11, 2021

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 13, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 24, 2011

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 19, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

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

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