BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    FDA Enforcement
    Class II ·Completed·Appliedvr·July 5, 2023

    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

    FDA Enforcement
    Class II ·Terminated·Virtual Imaging, Inc.·November 21, 2018

    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

    FDA Enforcement
    Class II ·Terminated·Virtual Imaging, Inc.·February 18, 2015

    vRad PACS with Mammography

    FDA Enforcement
    Class II ·Ongoing·Virtual Radiologic Corp.·August 2, 2023

    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

    FDA Enforcement
    Class II ·Completed·VIRTUAL INCISION CORPORATION·June 11, 2025

    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·April 1, 2020

    Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·December 13, 2023

    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·December 13, 2023

    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·December 13, 2023

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    The ZYTO Tower is the input device to program the software with various virtual items.

    FDA Enforcement
    Class II ·Terminated·ZYTO Technologies, Inc.·July 13, 2016

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·August 20, 2014

    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·August 20, 2014

    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·August 20, 2014

    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·May 20, 2020