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

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    Filters Classification: Class Ii ×

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·July 6, 2022

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    MAC VU360, Electrocardiograph

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 16, 2020

    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Bio-MAC Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 31, 2019

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·January 17, 2018

    BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·March 7, 2018

    MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

    FDA Enforcement
    Class II ·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024

    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054

    FDA Enforcement
    Class II ·Terminated·LumiQuick Diagnostics Inc.·April 16, 2014

    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Covidien·November 8, 2023

    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Covidien·November 8, 2023

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014