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

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·February 11, 2026

    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·October 18, 2023

    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·October 7, 2020

    RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·October 7, 2020

    EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·November 2, 2022

    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·March 4, 2026

    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·March 4, 2026

    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

    FDA Enforcement
    Class II ·Ongoing·Rebiscan, Inc.·November 9, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024

    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·July 24, 2024

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 26, 2025