BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO XIA STAINLESS STEEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950025299·NITROUS OXIDE HOSE ASSEMBLY 36" DISS FEMALE TO ...

    ALPHATEC

    FDA Adverse Event
    ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...

    Zavation

    FDA UDI
    Zavation LLC·00842166178496·Set of blades 90mm lateral

    Citrelock ACL 9mm Tibial Reamer

    FDA UDI
    Acuitive Technologies, Inc.·00810027271174·

    SOPRO 67D OPERATING ROOM CAMERA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 9, 2024

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·April 2, 2013

    STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 4, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 16, 2008

    HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024