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

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·July 31, 2013

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025

    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 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 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

    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·May 7, 2014

    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

    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 Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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

    American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 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 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

    American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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