BEUDAMED
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    360CAS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044201215·Sterile 30 mL Conical Centrifuge Tubes with Caps

    IPL Hair Removal

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Respiratory Gating for Scanners v2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·March 24, 2017

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    8F PRO-FUSE CT PLAST PORT

    FDA Adverse Event
    Injury ·MEDCOMP·Product code LJT·August 18, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026