BEUDAMED
    27 results · 18ms · Sources: EU EUDAMED, US FDA

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    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

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

    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 16, 2019

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·November 6, 2024

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Salyer Prn Biomedical·March 13, 2013

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·August 28, 2019

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·April 26, 2023

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·July 12, 2023

    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Enforcement
    Class II ·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    FDA Enforcement
    Class II ·Terminated·Pro-Med Instruments Gmbh·December 13, 2017

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    FDA Enforcement
    Class II ·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023