BEUDAMED
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    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·August 1, 2018

    Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·February 8, 2005

    Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code NHA·March 16, 2018

    Stryker brand Neptune waste management system; model 711-27-1.

    FDA Recall
    Terminated ·Stryker Instruments, Instruments Div.·Product code FYD·December 3, 2002

    MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.

    FDA Recall
    Terminated ·Wescam Inc 649 North Service Road West Burlington Canada Ontario·Product code RET·August 1, 2009

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    FDA Recall
    Terminated ·Access Vascular, Inc.·Product code LJS·February 24, 2021

    Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012

    Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018

    Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code FKP·November 20, 2009

    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine

    FDA Recall
    Terminated ·Medscience Inc·Product code LDH·March 22, 2016

    Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code KDI·November 20, 2009

    Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 07004 USA

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·October 1, 2001

    Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code KPO·November 20, 2009

    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code FKP·November 20, 2009

    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2015

    NucliSENS Lysis Buffer Extended lot for RES 76675

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code PPM·October 18, 2017

    Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HLF·May 19, 2010

    AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Recall
    Terminated ·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020