BEUDAMED
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    Filters FDA Enforcement × Status: Terminated × Clear all

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LTD.·March 7, 2018

    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·June 10, 2015

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    FDA Enforcement
    Class II ·Terminated·Heartsine Technologies, Limited·July 30, 2014

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LTD.·November 8, 2017

    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·September 9, 2015

    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·September 9, 2015

    PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    eye-pak 7407 Tray Support Cover REF 8065740745

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·October 1, 2014

    Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

    FDA Enforcement
    Class II ·Terminated·Trinity Sterile, Inc.·August 24, 2022

    Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

    FDA Enforcement
    Class II ·Terminated·Trinity Sterile, Inc.·August 24, 2022

    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

    FDA Enforcement
    Class III ·Terminated·Physio-Control, Inc.·March 16, 2022

    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020

    Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

    FDA Enforcement
    Class II ·Terminated·Trinity Sterile, Inc.·August 24, 2022

    Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·September 9, 2015

    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·September 9, 2015

    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·June 15, 2016

    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·May 17, 2017