BEUDAMED
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    MONDRIAN™ Anterior Lumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464033126·Alpha 7 FW 1.1.0

    BIOCRYL

    FDA UDI
    DEPUY MITEK, LLC·10886705010615·BIOCRYL INTERFERENCE SCREW Absorbable - TCP/PLA...

    Orfit Industries

    FDA UDI
    Orfit Industries NV·05420028755426·Arm Rest Plate for Upper Arm Supports and Wris...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022132·FPS 3.5/4.0mm Depth Gauge Assembly

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198473·HOFFMAN SHUNT PASSER SHORT

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506082511·2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ T H...

    ARIOL HER-2/NEU IHC

    FDA 510(k)
    FDA Class 2 ·Hematology

    Smart Toe II, X Fuse

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·July 12, 2013

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    FDA Enforcement
    Class II ·Completed·Vyaire Medical·December 13, 2023

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025