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

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

    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 Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G 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 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 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

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

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

    American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 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 Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 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

    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

    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