BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    RADIAL NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 13, 2022

    CONTOUR CURVED CUTTER STAPLER CS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    IVC ONE MEDIUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYNGO MULTIMODALITY WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 13, 2022

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 8, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 2, 2008

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    PRISMAFLEX SETS (HF)

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 22, 2023

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 26, 2023

    PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·XTANT MEDICAL INC·February 6, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018