BEUDAMED
    46 results · 24ms · 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 ×

    Giraffe OmniBed Carestation CS1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Symmetry Rochester-Pean

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482055717·Symmetry® Forceps, Rochester-Pean Baby, Straigh...

    Endo-Model®-M Rotational Knee Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575317295·Tibial Component x-small

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316298·Rotational Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316304·Rotational Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316281·Rotational Knee Joint Prosthesis,Tibial component

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575316243·Rotational Knee Joint Prosthesis,Tibial component

    LUMINA 1600, 3300 AND 6600 SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECYSYS SHBG

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962111239·ROCHESTER PEAN BABY FORCEPS, 5 1/2", STR

    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 24, 2022

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    MERGE HEMO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code DQK·September 24, 2024