BEUDAMED
    14 results · 17ms · Sources: EU EUDAMED, US FDA

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    Sorin CRM SAS

    FDA registration
    Sorin CRM SAS·11 products·🇫🇷 France

    Michelin AirProne Arm Module

    Device
    EU MDR · Eu Md Class 1 ·Manufacture Française des Pneumatiques MICHELIN·On the market

    Coussin Hemi Arm Positpro

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    ARMS, TORSO AND LEGS RE-EDUCATION DEVICES

    Device
    EU MDR · Eu Md Class 1 ·SMART MOBILITIES & DEVICES·On the market

    MANC-IRM-NI

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

    SKIF-IRM-NI

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Enforcement
    Class II ·Terminated·Sorin CRM SAS·August 22, 2018

    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Enforcement
    Class II ·Terminated·Sorin CRM SAS·August 22, 2018

    Mechanical articulated arm

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·KOELIS·4 devices

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·June 13, 2018