BEUDAMED
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    Acumen Hypotension Prediction Index (HPI) Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517192639·MaXcess Set Screw, Ctr Blade Self-Lock

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464021550·CORAL 7 FW 4.1

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198237·Bergstrom SMBN Skel Muscle Biop

    SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ESPIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 31, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 24, 2024

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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