BEUDAMED
    56 results · 27ms · Sources: EU EUDAMED, US FDA

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    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Recall
    Terminated ·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017

    SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·January 30, 2012

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

    Calcium Sulfate Hemihydrate 1.0 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

    Calcium Sulfate Hemihydrate 0.5 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code DZE·February 22, 2017

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    FDA Recall
    Open, Classified ·Ace Surgical Supply Co., Inc.·Product code NPM·February 2, 2022

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    Savaria SL-1000 Stairlift

    FDA Recall
    Terminated ·Savaria Concord Lifts, Inc.·Product code PCD·April 12, 2017

    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics·Product code PCH·February 22, 2019

    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift

    FDA Recall
    Open, Classified ·Acorn Stairlifts, Inc·Product code PCD·April 20, 2016

    Kit BD Max Enteric Viral Panel EU Catalog # 443985

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PCH·July 17, 2019

    Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.

    FDA Recall
    Terminated ·Luminex Corporation·Product code PCH·May 8, 2018

    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PCH·July 17, 2019

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 5, 2023

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·April 25, 2023