BEUDAMED
    27 results · 21ms · Sources: EU EUDAMED, US FDA

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    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105510·Zirlux 15 Degree Titanium Esthetic Abutment Ant...

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150852·Endo Carry-on Procedure Kit contains Basin, Int...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345027961·Lumbar Inserter, PLIF, 7-10H

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105010·Implant Inserter, 11-13mm, Sleeved

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

    IMAGE X-70 PLUS DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·July 9, 2010

    POLY-TAPE, 20 X 500MM

    FDA Adverse Event
    Injury ·XIROS·Product code JDR·December 6, 2011

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM (ACCESS® 2 PORTION)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·March 19, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 1, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 14, 2014

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-VS·Product code NTE·December 23, 2010

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 7, 2024

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.

    FDA Recall
    Terminated ·Medrad Inc·Product code JAK·October 7, 2005

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023