BEUDAMED
    26 results · 27ms · Sources: EU EUDAMED, US FDA

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    Adapter (U17-13P2-E)

    Device
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·On the market·1 country

    AUTION Diluent (BAC)

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    AUTION Staining Solution (BAC)

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    C30-E-AC

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·1 device

    AUTION Diluent (BAC)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    AUTION Staining Solution (BAC)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    Adapter

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device

    Nakanishi Inc.

    System producer
    🇯🇵 Japan

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

    FDA Enforcement
    Class II ·Terminated·Canon Inc.·September 5, 2012

    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. 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·Canon Inc.·June 5, 2013

    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018