BEUDAMED
    33 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·April 16, 2014

    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

    FDA Enforcement
    Class II ·Completed·Baxter Healthcare Corp.·March 25, 2015

    AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 5, 2013

    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·October 21, 2015

    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 1, 2014

    Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

    Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016