BEUDAMED
    12 results · 21ms · 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 Country: France ×

    FAX INTERNATIONAL OPHTALMICS INSTRUMENTS

    Importer
    🇫🇷 France·10 Manufacturers

    SiVIEW BOX V2

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·SiVIEW·6 devices

    Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    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

    PROCESS FOR PRF

    Authorized representative
    🇫🇷 France·1 Manufacturer

    For Health Consulting

    Authorized representative
    🇫🇷 France

    lames de gouges La Gouge Box - échantillon - boite de 25

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·COBLENTZ MEDICAL BLADES INDUSTRY·1 device

    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    FDA Enforcement
    Class II ·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025

    stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025