BEUDAMED
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    MyoCycle Home, MyoCycle Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    EarQ

    FDA UDI
    Oticon A/S·05707131318596·G50, MRITE 312 2.4G NFM PB C044 EARQ

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776163860·VAN BUREN URETH SNDS FR

    Medline/MMS Sales

    FDA UDI
    MEDLINE INDUSTRIES, INC.·20080196984340·CIRCUIT-ADULT ANESTHESIA

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8961701320·Osteotome concav...

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10080196984343·CIRCUIT-ADULT ANESTHESIA

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132611·IN-OVATION® C Roncone 022 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132101·IN-OVATION® C Base Rx 022 U3-3 CS HK

    MUSE CARDIOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIPORE, MODELS HA, BP90, BP15

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·June 22, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORP·Product code LZG·June 6, 2013

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·October 14, 2014

    Allura CV20, system code 722031

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    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