BEUDAMED
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    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Smart Blood Analytics Swiss SA

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

    BIOSTI (Swiss technology of implantology and biomaterials) GmbH

    Manufacturer
    🇨🇭 Switzerland

    ASSOS OF SWITZERLAND SA

    FDA registration
    ASSOS OF SWITZERLAND SA·1 product·🇨🇭 Switzerland

    SWISS PHARMA DYNAMIC LTD Zweigniederlassung

    Manufacturer
    🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

    Biosensors Europe SA

    Manufacturer
    🇨🇭 Switzerland·185 Basic UDI-DIs·185 Devices·1 Importer·National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    VIRUS vs. BACTERIA

    Device
    EU MDR · Eu Md Class 2a ·Smart Blood Analytics Swiss SA·On the market·32 countries

    SBAS Software

    Device
    EU MDR · Eu Md Class 2a ·Smart Blood Analytics Swiss SA·On the market·32 countries

    CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Device
    EU MDD · Eu Md Class 3 ·Biosensors Europe SA·On the market·32 countries

    CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Device
    EU MDD · Eu Md Class 3 ·Biosensors Europe SA·On the market·32 countries

    CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Device
    EU MDD · Eu Md Class 3 ·Biosensors Europe SA·On the market·32 countries

    CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Device
    EU MDD · Eu Md Class 3 ·Biosensors Europe SA·On the market·32 countries

    CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Device
    EU MDD · Eu Md Class 3 ·Biosensors Europe SA·On the market·32 countries