BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPERMCHECK FERTILITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    Bur PM2-125 80K Mstick Ø3.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055503128·

    Bur PM2-125 80K matchstick Ø3.0mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003410011·

    IN-OVATION® Czr

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100341001·IN-OVATION® CZR Base Rx .018 LR4 -17T -1A 4D

    IN-OVATION® Czr

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100341101·IN-OVATION® CZR Base Rx .018 LR4 -17T -1A 4D HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK

    MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,

    FDA 510(k)
    FDA Class 2 ·Neurology

    14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

    FDA 510(k)
    FDA Class 2 ·Radiology

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 18, 2010

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MAF·March 9, 2021

    DEXTRUS MED ACCESS RETRACTOR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·May 8, 2013

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 18, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Other ·UNKNOWN·Product code ITJ·May 12, 2011

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·April 27, 2010

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024