BEUDAMED
    52 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·April 22, 2015

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·NOBEL BIOCARE SERVICES AG·August 26, 2020

    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

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

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

    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

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    FDA Enforcement
    Class II ·Terminated·Allergan PLC·February 10, 2021

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    FDA Enforcement
    Class II ·Terminated·Covidien, PLC·March 27, 2019

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    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

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012

    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013