BEUDAMED
    47 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·June 14, 2017

    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Company Inc.·March 6, 2013

    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 11, 2014

    First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 19, 2014

    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 19, 2014

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.

    FDA Enforcement
    Class II ·Terminated·Advanced Medical Solutions Ltd.·September 14, 2016

    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.

    FDA Enforcement
    Class II ·Terminated·Advanced Medical Solutions Ltd.·September 14, 2016

    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 22, 2014

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Single Detector (Stitching Patient Support) 712020

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    CombiDiagnost R90 (Stitching Patient Support) 709030

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018