BEUDAMED
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    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552020004·33" Width Flat Deck Patient Repositioner

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·M988DFSA3N·33" Width Flat Patient Repositioner

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·M988DFSA9·39" Width Flat Patient Repositioner

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·M988DFSA3R·33" Width Raised Patient Repositioner

    Advanced Wave HX, Hercules Mattress System

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552022473·Hercules Patient Repositioning Device with Adva...

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·M988DVSA5·35" Width VersaCare Patient Repositioner

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·M988DFSA5·35" Width Flat Patient Repositioner

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552020042·39" Width Flat Deck Patient Repositioner

    Hercules Air Mattress Controller

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552022343·Controller, Kap Medical, Revision A

    Hercules

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552020059·35" VersaCare Patient Repositioner

    Hercules Mattress

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552022336·Hercules Patient Repositioner with Mattress Pne...

    MATTRESS COVER FOR THE HERCULES PATIENT REPOSITIONER

    FDA Adverse Event
    Injury ·THE MOREL COMPANY, LLC·Product code FNL·September 21, 2023

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    FDA Enforcement
    Class II ·Terminated·Fisher Diagnostics·August 2, 2017

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    FDA Enforcement
    Class II ·Terminated·Fisher Diagnostics·August 2, 2017

    Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code LKF·May 30, 2019

    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JHI·May 25, 2022

    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

    FDA Recall
    Open, Classified ·Touch US Llc·Product code NBW·June 21, 2022

    a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code MED·May 25, 2022

    Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.

    FDA Recall
    Terminated ·Infantino LLC·Product code MEF·January 6, 2014