BEUDAMED
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    Harvest Dental Polymer Blocks

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPREHENSIVE REVERSE SHOULDER

    FDA UDI
    Biomet Orthopedics, LLC·00880304673045·

    Comprehensive® Reverse Shoulder

    FDA UDI
    Biomet Orthopedics, LLC·00887868471209·

    World Knee Offset Tibial Omnicut Block Slim - RMLL

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215075132·

    ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    1024879-2016-00039

    FDA Adverse Event
    Injury ·September 26, 2016

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 20, 2013

    PALMAZ GENESIS AMIIA

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code FGE·July 27, 2011

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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