BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013

    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2013

    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    FDA Enforcement
    Class II ·Terminated·CSA Medical·April 29, 2015

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    FDA Enforcement
    Class II ·Terminated·Medistim Asa·March 7, 2018

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015

    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.

    FDA Enforcement
    Class II ·Terminated·Richard-Allan Scientific Company·May 10, 2017

    Arrow SPINAL ANESTHESIA SET ASA-25090-S

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 26, 2020

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    FDA Enforcement
    Class II ·Terminated·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·June 1, 2016

    Philips Network Firewall (Cisco ASA 5506), Model # 867098

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 14, 2018

    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.

    FDA Enforcement
    Class II ·Terminated·Westone Laboratories, Inc.·August 1, 2012

    Discovery RT labeled as: a. MID BJG; b. HVY BJG

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.

    FDA Enforcement
    Class II ·Terminated·Thayer Intellectual Property, Inc.·December 14, 2016

    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·October 9, 2019

    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 12, 2013

    TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Surgical Vision Inc·October 13, 2021

    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·September 4, 2013

    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·December 11, 2013