BEUDAMED
    198 results · 103ms · Sources: EU EUDAMED, US FDA

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    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·June 20, 2012

    Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·June 20, 2012

    Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·June 20, 2012

    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·March 20, 2013

    GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·January 2, 2013

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·August 26, 2020

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    FDA Enforcement
    Class II ·Terminated·Fisher Diagnostics·August 2, 2017

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    FDA Enforcement
    Class II ·Terminated·Fisher Diagnostics·August 2, 2017

    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    FDA Recall
    Terminated ·Vygon Corporation·Product code NZW·May 11, 2012

    Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens

    FDA Recall
    Terminated ·Vygon Corporation·Product code NZW·May 11, 2012

    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·July 3, 2013

    ID NOW STREP A 2

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code PGX·October 18, 2019

    Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    FDA Recall
    Terminated ·Vygon Corporation·Product code NZW·May 11, 2012

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 20, 2021

    CURAPLEX

    FDA Adverse Event
    Injury ·BOUND TREE MEDICAL, LLC·Product code CAE·February 28, 2020

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·August 30, 2017

    INTELISWAB COVID-19 RAPID TEST

    FDA Adverse Event
    Malfunction ·ORASURE TECHNOLOGIES, INC.·Product code QKP·January 12, 2023

    ADELANTE PEEL-AWAY INTRODUCER SET

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 21, 2024

    PNEUPAC VENTIPAC WITH ALARMS

    FDA Adverse Event
    Malfunction ·Product code BTL·November 18, 2009

    IHEALTH

    FDA Adverse Event
    Malfunction ·ANDON MEDICAL CO.,LTD·Product code QKP·March 21, 2023