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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017