BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950013067·VELCRO STRAP 1X24" W/BUCKLE L/F

    SlimLine®

    FDA UDI
    ZIMMER SPINE, INC.·00889024403482·

    AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 24mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009323·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380240·Handle, Threaded Stream Line Impact

    PASS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYBERKNIFE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIVONA TTS ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·March 11, 2025

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 28, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 4, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013