BEUDAMED
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    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 26, 2012

    Vanguard 360 Revision Knee System Knee prostheses

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 12, 2016

    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 24, 2024

    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical Inc·May 11, 2016

    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

    FDA Enforcement
    Class II ·Ongoing·The See Clear Company·March 15, 2017

    Arjo Disposable Repositioning Sling, Model AHD001

    FDA Enforcement
    Class II ·Terminated·Getinge Dominican Republic SA·September 22, 2021

    Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024