BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Versacryl

    FDA UDI
    Keystone Industries·H66810140151·Reline Softening Liquid 1 Qt

    ANODYNE Plate System

    FDA UDI
    CORELINK LLC·M7252014015·ANODYNE CERVICAL SCREW - VARIABLE SELF DRILLIN...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193101927·EVOS Straight HA PEEK 15mm x 9mm x 22mm Flat, 5...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710630140150·2nd TMT Joint Cut Guide, 14mm x 15mm

    INSTANT-VIEW METHADONE URINE CASSETTE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BEAM BLOCK TRAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    INTEGRITY ADX DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011

    UNIVERSAL DRIVER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code HXX·March 13, 2008

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 4, 2013

    ACT PLUS INSTRUMENT

    FDA Adverse Event
    Malfunction ·PERFUSION SYSTEMS·Product code GKN·July 7, 2023

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

    FDA Enforcement
    Class II ·Terminated·Primus Medical LLC·November 14, 2012

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015