BEUDAMED
    58 results · 19ms · Sources: EU EUDAMED, US FDA

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    American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·September 16, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 16, 2015

    American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016