BEUDAMED
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    PoreStar Patient Specific Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·December 20, 2017

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·October 14, 2014

    UNKNOWN_SPINE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code NKB·June 14, 2013

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DWA·July 1, 2011

    INVISION¿ TOTAL ANKLE SYSTEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026