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

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    NEBULIZER WITH AIR ENTERTAINER & ETC.

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00148012520·2G Wide VS5

    EXPEDIUM 4.5MM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ART PILLOW 8MM PUMP SEGM UNIVE

    FDA Adverse Event
    Malfunction ·ERIKA DE REYNOSA·Product code FJK·July 24, 1998

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    DEPUY ASR XL FEM IMP 45MM

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·August 11, 2010

    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·December 25, 2013

    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

    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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024