BEUDAMED
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    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·July 16, 2014

    RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.

    FDA Recall
    Terminated ·Sleep Modus·September 15, 2010

    Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.

    FDA Recall
    Terminated ·Solafeet, Inc.·Product code REG·September 8, 2009

    BrightView XCT , Model Number 882482

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 10, 2019

    BrightView SPECT, Model Number 882480

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 10, 2019

    BrightView X , Model Number 882478

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 10, 2019

    RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

    FDA Enforcement
    Class II ·Terminated·Reflexion Medical, Inc.·January 19, 2022

    TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·January 30, 2013

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    FDA Enforcement
    Class I ·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013

    TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

    FDA Recall
    Terminated ·ConMed Corporation·Product code GEI·December 27, 2012

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    FDA Recall
    Terminated ·Fisher & Paykel Healthcare, Ltd.·Product code BZO·November 19, 2012

    3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.

    FDA Recall
    Terminated ·Invivo Corporation·Product code MWI·August 13, 2008

    Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·March 2, 2016

    Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA

    FDA Recall
    Terminated ·Product code FFZ·January 25, 2001

    REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code FZX·February 10, 2011

    BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.

    FDA Enforcement
    Class II ·Terminated·OPTI Medical Systems, Inc·October 3, 2012

    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 10, 2011

    Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower

    FDA Recall
    Terminated ·North Coast Medical Inc 8100 Camino Arroyo·Product code IKX·March 20, 2012

    GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·March 28, 2012

    Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FRJ·January 20, 2016