BEUDAMED
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    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 2, 2023

    Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·March 25, 2026

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Enforcement
    Class II ·Ongoing·Precision Valve & Automation,Inc·August 26, 2020

    Heel Snuggler, Reference # 989805603411 99047

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 26, 2022

    Infa-Therm Transport Mattress, Reference Number 989805616831 1015

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 26, 2022

    Infant Heel Warmers w/strap, Reference # 989805603201 1223

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 26, 2022

    Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 26, 2022

    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 26, 2022

    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

    FDA Enforcement
    Class II ·Ongoing·Cypress Medical Products LLC·September 25, 2024

    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·May 13, 2020

    Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·May 13, 2020

    Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·April 8, 2020

    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·April 8, 2020

    Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·April 8, 2020

    Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·April 8, 2020

    Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·May 13, 2020

    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·May 13, 2020