BEUDAMED
    85 results · 12ms · Sources: EU EUDAMED, US FDA

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    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

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

    Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room

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

    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·September 7, 2016

    General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room

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

    Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room

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

    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.

    FDA Recall
    Terminated ·Milestone Scientific, Inc.·Product code EJI·February 11, 2015

    Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room

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

    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room

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

    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

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

    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy·Product code HSD·August 14, 2015

    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

    FDA Recall
    Terminated ·Valeant Pharmaceuticals North America LLC·Product code CAF·September 14, 2015

    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room

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

    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room

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

    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy·Product code KWT·August 14, 2015