BEUDAMED
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    Glovmaster Nitrile Examination Glove Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111014727·MAYO HEGAR NH SERR 14" TC

    VPAP TX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SONICWAVE SONIC PLAQUE REMOVER

    FDA 510(k)
    FDA Class 1 ·Dental

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 30, 2014

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Injury ·CAREFUSION CORPORATION·Product code FPA·August 3, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·March 7, 2023

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·August 22, 2023

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·CERENOVUS, INC.·Product code KRD·August 22, 2023

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026