BEUDAMED
    20 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 ×

    ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508222·

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702598575·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE/SOFTFIT-SL...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702256703·Elvarex 2/Thigh High/Slant, Closed Toe, E-Versi...

    Steinmann Pin plain Ø 1.60mm Trocar - Round shank

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613292914·

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 28, 2021

    DUAL PORT SPATULA

    FDA UDI
    The Wells Johnson Company·B458201216000·Cannula, Dual Port Spatula, specify length, dia...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971383·

    INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED HAND ACTIVATE SEALER/DIVIDER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD SAFETYGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·November 13, 2019

    IDENTITY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 16, 2013

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 2, 2011

    TRULIANT TIB IMP PS INSERT SZ 5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013

    RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·September 12, 2023

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022