BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    RSL (125 L) PROGESTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517134929·Helix R Plate, 26mm 1-Level

    NHAC 3.0T SMS

    FDA UDI
    LMT Medical Systems GmbH·04260486610155·No description.

    Convaid

    FDA UDI
    CONVAID PRODUCTS, INC.·00840117408777·

    Opaque

    FDA UDI
    Kerr Corporation·00841396108020·Resin Based Dental Restorative Material - Cervical

    ORTHO ARCH

    FDA UDI
    Ortho Arch Company Inc·D90980012614·SLB OPENING TOOL

    ACUMED

    FDA UDI
    Acumed LLC·10806378040092·Universal Tray Clavicle Plate Insert Lid

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIO PROTEM IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012

    JOURNEY TOTAL KNEE FEMORAL COMPONENT, TIBIAL COMPONENT, TIBI

    FDA Adverse Event
    Malfunction ·SMITH AND NEPHEW·Product code JWH·July 18, 2010

    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·December 12, 2018

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022