BEUDAMED
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    D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517573704·CoRoent Ant TLIF Ti, 10x11x36mm 8°

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58211013680·SCISSORS, SURGICAL TISSUE, DENTAL

    Bur PM2-70 80K steel Ø0.5 St

    FDA UDI
    Bien-Air Surgery SA·17630055519389·

    HHM

    FDA UDI
    Oticon A/S·05707131163332·K140, MINIRITE CNB HHM

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010030580·3/4 RING 40MM FOR SMALL BONE FIXATOR

    Ear Tip ET-LT60M Pack/100 pcs.

    FDA UDI
    PATH medical GmbH·04260223146640·

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756753517·Youth ER Wrist Brace

    Recon

    FDA UDI
    Revelation Medical Devices·G318101368050·Femoral Hip Retractor

    DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

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

    PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AZURE XT DR MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·October 21, 2024

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLQ·May 3, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTHA MERICA·Product code KPO·September 3, 2014

    TECNIS MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·May 24, 2011

    PLASMABLADE 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code DWG·January 9, 2015

    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021