BEUDAMED
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    PET VCAR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comprehensive® SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304540514·

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112556·HALO, 1203-5 VEST LARGE, ACRYLIC LINER, 1211-1 ...

    CRANIAL REMOLDING ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    LS CLAVE PORT EXT 7"

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 16, 2008

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 15, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    LINER #L FOR MOBILE LINER Ø42

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·February 15, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026