BEUDAMED
    30 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·September 2, 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 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 Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 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 Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S 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 Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 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 10 mm x 13 mm Ref Number: 63-03 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

    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

    FDA Enforcement
    Class II ·Terminated·Zipline Medical·March 11, 2015