BEUDAMED
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    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

    FDA Recall
    Terminated ·Strata Skin Sciences, Inc.·Product code GEX·January 23, 2017

    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLG·August 2, 2016

    Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L

    FDA Recall
    Open, Classified ·NuVasive Inc·Product code MJO·June 20, 2022

    Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous Insulin Infusion for the control of diabetes.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008

    Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code LPH·September 5, 2012

    Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·November 19, 2020

    In-View Clear Leggings Sterile Non-Sterile

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code ILG·February 25, 2021

    BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

    FDA Recall
    Open, Classified ·Young Dental Manufacturing I, LLC·Product code FLG·August 23, 2024

    Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·June 22, 2006

    In-View Clear Leggings Sterile

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code ILG·February 25, 2021

    Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·June 22, 2006

    Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system

    FDA Recall
    Open, Classified ·Ultra Clean Systems, Inc.·Product code FLG·March 31, 2025

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·June 26, 2020

    Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005

    FDA Recall
    Terminated ·Pacific Bioscience Lab, Inc.·Product code FLG·July 3, 2007

    In-View Clear Leggings Bulk Non-Sterile

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code ILG·February 25, 2021

    Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014

    Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014

    Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014

    Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014