BEUDAMED
    117 results · 16ms · Sources: EU EUDAMED, US FDA

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    Helio Kids; Apex P

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SUPER CHAIR FOR KIDS BY ORION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    RAPID AID CORP.

    FDA registration
    RAPID AID CORP.·6 products·🇨🇦 Canada

    SAFECROSS FIRST AID LTD.

    FDA registration
    SAFECROSS FIRST AID LTD.·2 products·🇨🇦 Canada

    BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.

    FDA Enforcement
    Class II ·Terminated·Bomimed·October 11, 2017

    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

    FDA Enforcement
    Class II ·Terminated·Intellijoint Surgical, Inc.·April 1, 2020

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017

    Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.

    FDA Enforcement
    Class II ·Terminated·Abbott Point of Care Canada Limited·January 30, 2013

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017

    ORAgene (Swab-based DNA & Dx Collection Device)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

    Testosterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Testosterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Resistin ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Prolactin (PRL) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Free Estriol ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Anti-Thyroglobulin (Anti-Tg) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device