BEUDAMED
    7 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    FDA Enforcement
    Class II ·Completed·Materialise N.V.·August 9, 2023

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·July 7, 2021

    Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

    FDA Enforcement
    Class II ·Ongoing·Cordis US Corp·March 19, 2025

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·September 25, 2024