BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED ENT SHAVERS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Hillrom™

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761976153·Trumpf Medical/Medizin Pad Carbon X-TRA 7500 sh...

    Pads

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761969100·Pad Carbon X-TRA 7500 short G

    Sof-Flex

    FDA UDI
    COOK INCORPORATED·00827002149342·Sof-Flex Loop Suprapubic Catheter Set

    AMEDITECH IMMUTEST DRUG SCREEN COC

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 29, 2013

    ALARIS INFUSION PUMP - LARGE VOLUME MODULE

    FDA Adverse Event
    Injury ·CARDINAL HEALTH·Product code FRN·May 3, 2011

    PUMP MMT-722NAB PRDGM INS BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

    FDA Enforcement
    Class I ·Terminated·Verathon, Inc.·March 16, 2016

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015