BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Diamed GmbH

    Manufacturer
    🇨🇭 Switzerland·4 Importers

    SIC invent AG

    Manufacturer
    🇨🇭 Switzerland·1 Importer

    BIO BREM SA

    Manufacturer
    🇨🇭 Switzerland·1 Basic UDI-DI·3 Devices

    Smart Blood Analytics Swiss SA

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Flow®

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Oss®

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

    FDA 510(k)
    FDA Class 2 ·Dental

    Self Therapy

    Device
    EU MDR · Eu Md Class 2a ·BIO BREM SA·On the market·1 country

    Self Therapy Enbios

    Device
    EU MDR · Eu Md Class 2a ·BIO BREM SA·On the market·1 country

    Self Therapy Pocket

    Device
    EU MDR · Eu Md Class 2a ·BIO BREM SA·On the market·1 country

    Self Therapy

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·BIO BREM SA·3 devices

    SIE AG, Surgical Instrument Engineering

    System producer
    🇨🇭 Switzerland

    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Enforcement
    Class II ·Terminated·SIE AG, Surgical Instrument Engineering·April 4, 2018

    MDR-006

    Certificate
    MDR QMS·Smart Blood Analytics Swiss SA·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ