BEUDAMED
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    MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDFUSION® 3500 SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·November 28, 2017

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 8, 2013

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    PRK LASIK

    FDA Adverse Event
    Injury ·Product code LZS·May 10, 2008

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018