BEUDAMED
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    WELL-TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Natus

    FDA UDI
    XLTEK·00382830009171·EXTERNAL EMU40 BATTERY PACK

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450275009·

    PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·November 26, 2018

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    MULTI-LINK 8

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·March 13, 2013

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO. LTD.·Product code DZE·February 22, 2008

    PICC-NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 10, 2025

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024