BEUDAMED
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    Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    Universal Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357234912·

    GLOBAL

    FDA UDI
    DEPUY (IRELAND)·10603295105305·GLOBAL GLENOID TRIAL SIZER 48mm

    BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CURRENT RF VR

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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