BEUDAMED
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    PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2726 HEAD SUPPORT

    FDA UDI
    HANS RUDOLPH, INC.·00817136026725·HG SST ROD 1.35/1.25OD SNAPFIT

    NEWDEAL INTERPHALANGEAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    ALYTE Y-MESH GRAFT

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code OTO·May 9, 2013

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    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·June 10, 2008

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL·Product code MKJ·May 24, 2011

    ADAP-2000 DISPOSABLE PACING CABLE

    FDA Adverse Event
    Malfunction ·REMINGTON MEDICAL, INC.·Product code DSA·June 28, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021