BEUDAMED
    124 results · 21ms · Sources: EU EUDAMED, US FDA

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

    FDA Recall
    Completed ·Appliedvr·Product code QRA·February 27, 2023

    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 Recall
    Terminated ·Virtual Imaging, Inc.·Product code MQB·November 2, 2018

    vRad PACS with Mammography

    FDA Recall
    Open, Classified ·Virtual Radiologic Corp.·Product code LLZ·May 9, 2023

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

    FDA Recall
    Terminated ·Virtual Imaging, Inc.·Product code IZL·September 22, 2014

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

    FDA Recall
    Completed ·VIRTUAL INCISION CORPORATION·Product code SAB·April 23, 2025

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

    FDA Recall
    Terminated ·ZYTO Technologies, Inc.·Product code GZO·November 23, 2015

    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 Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 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 Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014

    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 Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·March 4, 2020

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

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

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

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 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 Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015

    Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014

    Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014

    Codman Certas - In Line Valve Only; Product Code: 82-8800 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·June 25, 2015

    Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 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 Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014