BEUDAMED
    22 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    Brow Pack, part number PSS1785(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Surgical Pack, part number PSS3540(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Dr. Casey Pack, part number AMS4313(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

    FDA Enforcement
    Class II ·Terminated·Vivorte, Inc.·July 14, 2021

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    General Plastics Pack, part number 008617-1

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Custom Pack - with Introducer Kit, part number TVS4011NI(L

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.

    FDA Enforcement
    Class II ·Terminated·Richard-Allan Scientific Company·May 10, 2017

    Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017