BEUDAMED
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    REGIONAL INTRAVENOUS ANESTHESIA KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Synergy

    FDA UDI
    Rmo, Inc.·00885797100948·DOLICH SY 185 HK MX/3 5-5 20EA

    ADVIA® Chemistry AMM Ammonia Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414555898·Ammonia - ADVIA Chem. - RGT - 2x138 tests

    NEURON DELIVERY CATHETER 070

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 16, 2010

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007

    POWERED PATIENT ROTATION BED

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code IKZ·October 23, 2012

    NGAGE

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code FFL·April 29, 2014

    ONYX FRONTIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·August 3, 2023

    ENDURANT IIS BIFURCATED STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·April 22, 2024

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 9, 2025

    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025