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

    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·June 8, 2016

    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·December 20, 2023

    GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.

    FDA Enforcement
    Class II ·Terminated·AMS Innovative Center - San Jose·January 30, 2013

    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

    FDA Enforcement
    Class II ·Terminated·ConBio, a CynoSure Company·July 3, 2013

    Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

    FDA Enforcement
    Class II ·Terminated·The Standing Company·February 26, 2014

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    FDA Enforcement
    Class II ·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016

    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    FDA Enforcement
    Class II ·Terminated·Circadiance LLC·June 14, 2017

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·September 25, 2024

    Regard Kit containing the Microtek decanter

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·August 28, 2024

    Regard Dressing Change Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·May 19, 2021

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·March 9, 2022

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·June 15, 2022

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 6, 2022

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014