BEUDAMED
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    Ace Medical Surgical Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    CUSHING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084773·CUSHING FORCEPS WITH TUNGSTEN CARBIDE PLATFORM ...

    FANOUS SABERBACK SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054882·FANOUS SABERBACK SCISSORS CURVED TENOTOMY TIP P...

    FANOUS SABREBACK SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896099593·FANOUS SABREBACK SCISSORS TENOTOMY CURVED POWER...

    TERUMO NEEDLE WITH LOCKING SHEATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MYALLERGYTEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 10, 2024

    CEEON

    FDA Adverse Event
    PHARMACIA & UPJOHN GRONINGEN BV·Product code HQL·October 1, 2003

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 28, 2017

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code GKZ·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·August 11, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·July 1, 2013

    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020