BEUDAMED
    13 results · 35ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Medimaps Group SA

    FDA registration
    Medimaps Group SA·1 product·🇨🇭 Switzerland

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3100·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3120·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI30·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3110·TBS iNsight is a software provided for use as a...

    Medimaps TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI0·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI303·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSIV400·TBS iNsight is a software application provided ...

    Phantom

    FDA UDI
    medimaps group SA·B214OSPTM3·

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Enforcement
    Class II ·Ongoing·Medimaps Group·March 12, 2025

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Enforcement
    Class II ·Terminated·Medimaps Group·November 16, 2016

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Recall
    Terminated ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Recall
    Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025