BEUDAMED
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    MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Stratosphere

    FDA UDI
    HENRY SCHEIN, INC.·H65810028501·Stratosphere 2 Spill 600mg Fast Set 50 jar

    Mariner MIS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981171414·MIS Tap A/O, Dia 8.50mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450174425·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009436·PedFuse Reset, CNL, 9.0mm x 50mm

    L3W0900 - AQUACEL AG

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 20, 2021

    L3W0900 - AQUACEL AG

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 20, 2021

    STAND. ACETAB. CEM. CUP Ø52MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LPH·June 6, 2023

    SONICAID FM820, SONICAID FM830

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    REFACTO LABORATORY STANDARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    ELECTRIC MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 12, 2014

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·February 16, 2011

    EVIS EXERA LLL COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·April 25, 2022

    EVIS EXERA LLL COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·April 25, 2022

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Recall
    Open, Classified ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·November 15, 2018

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·December 4, 2019

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    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

    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