BEUDAMED
    243 results · 12ms · Sources: EU EUDAMED, US FDA

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    FPS 35mm x 3.5 mm non-locking screw

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·September 28, 2016

    ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·October 20, 2020

    ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·October 20, 2020

    FPS 35mm x 3.5 mm non-locking screw

    FDA Recall
    Terminated ·Ortho Solutions Inc·Product code HWC·July 21, 2016

    Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2

    FDA Recall
    Terminated ·The OR Group·Product code FPS·November 6, 2003

    Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A

    FDA Recall
    Terminated ·The OR Group·Product code FPS·November 6, 2003

    ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.

    FDA Recall
    Terminated ·MDC Acquisition Co.·Product code FPS·April 23, 2010

    Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1

    FDA Recall
    Terminated ·The OR Group·Product code FPS·November 6, 2003

    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 Recall
    Terminated ·Circadiance LLC·Product code NPE·May 1, 2017

    APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code NPF·October 15, 2007

    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

    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 Recall
    Terminated ·Spiegelberg Gmbh & Co. KG Tempowerkring 4 Hamburg Germany·Product code GWM·December 29, 2009

    Regard, T AND A - Rogers, sterilized convenience kits

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OGR·November 30, 2021

    regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJK·October 20, 2022

    regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJH·October 20, 2022

    regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJG·October 20, 2022

    regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJG·October 20, 2022

    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

    FDA Recall
    Terminated ·ROi CPS LLC·Product code FTN·April 20, 2020