BEUDAMED
    86 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·February 5, 2014

    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·February 5, 2014

    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

    FDA Enforcement
    Class II ·Terminated·Cenorin, LLC·July 16, 2014

    Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

    FDA Enforcement
    Class II ·Ongoing·DJO, LLC·December 3, 2025

    DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

    FDA Enforcement
    Class II ·Ongoing·DeVilbiss Healthcare LLC·December 28, 2022

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·April 11, 2018

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·December 25, 2024

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Infant Warmer System (IWS)

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 18, 2017

    Infant Warmer System (IWS)

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

    Proteus 235 Proton Therapy System for cancer treatment.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·November 5, 2014

    Hitachi Oasis MRI System - C-Spine Coil

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·February 1, 2017

    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·April 11, 2018

    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Health Sciences Canada, Inc.·December 5, 2018

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee multi-purpose, Model Number 10094139

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 13, 2021

    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

    FDA Enforcement
    Class II ·Terminated·Zynex Medical, Inc.·July 2, 2014