BEUDAMED
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    SYNVITRO FLUSH

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

    Premier Curettes

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783007787·CURETTE DE SURGICAL 85

    QIAstat-Dx® Rise

    FDA UDI
    QIAGEN GmbH·04053228041849·The QIAstat-Dx Rise system is intended as an in...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM

    PM 2002 PROLINE/AEC

    FDA 510(k)
    FDA Class 2 ·Dental

    DMLC IV-ERGO

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 12, 2024

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·December 31, 2014

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 11, 2024

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·Product code FPA·May 10, 2024

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 18, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 12, 2014

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·Product code FPA·May 10, 2024

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·Product code FPA·May 10, 2024

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·Product code FPA·May 10, 2024

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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