BEUDAMED
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    ACAPELLA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110099·DURA-CUF, THIGH, 1 TB SCREW, 38 - 50 CM, SINGLE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450198094·

    OCCU-FLO PUNCTUM PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    TRIFLEX LATEX SURGEON'S GLOVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE SYSTEM·Product code KGO·July 8, 1994

    ASSURITY MRI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·October 15, 2025

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 13, 2013

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

    REVOLUTION XR/D-2X

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC.·Product code MQB·February 26, 2008

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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