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    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 Recall
    Terminated ·ConMed Corporation·Product code GFF·December 21, 2015

    GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·April 17, 2007

    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 Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·December 11, 2012

    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·January 22, 2010

    American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·June 18, 2007

    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 Recall
    Terminated ·ConBio, a CynoSure Company·Product code GEX·May 9, 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 Recall
    Terminated ·The Standing Company·Product code IPL·May 16, 0013

    MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors.

    FDA Recall
    Terminated ·Mira, Inc.·Product code HPS·April 8, 2010

    MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.

    FDA Recall
    Terminated ·Mira, Inc.·Product code HPS·April 8, 2010

    MIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for the destruction of tumors.

    FDA Recall
    Terminated ·Mira, Inc.·Product code HPS·April 8, 2010

    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 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

    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

    FDA Recall
    Terminated ·ROi CPS LLC·Product code MLS·October 12, 2020