BEUDAMED
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    TRILOGY 200 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198260·AK3 PS Insert Trial Size 4, 16mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134160·Trial, TLIF, 27L OB STR 7Deg, 16mm

    MODIFICATION TO VKS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 22, 2024

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·September 16, 2014

    NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code MBH·April 12, 2011

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012