BEUDAMED
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    CEMENT EXTRACTOR DRILL

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471188279·.022 U/R Std. Weld Size #4

    LINK TO ACUITY CLINICIAN NOTIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FFR Link, FFR Signal Processing Module

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    ADVANCED PATELLA 32MM 3 PEG IMPLANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 7, 2025

    AFFINITY OXY NT 511

    FDA Adverse Event
    Malfunction ·PERFUSION SYSTEMS·Product code DTZ·April 24, 2014

    XIA 3 PROBE

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·October 1, 2012

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 21, 2010

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020