BEUDAMED
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    G-CINCH SUTURE GRASPER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964077371·Endo Carry-On Procedure Kit

    thalaset™

    FDA UDI
    Unomedical A/S·05705244005433·Single use infusion set for subcutaneous infusi...

    neria™

    FDA UDI
    Unomedical A/S·05705244003491·Single use infusion set for subcutaneous infusi...

    neria™

    FDA UDI
    Unomedical A/S·05705244000230·Single use infusion set for subcutaneous infusi...

    thalaset™

    FDA UDI
    Unomedical A/S·05705244001473·Single use infusion set for subcutaneous infusi...

    METRX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·May 9, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 19, 2014

    HUTIV FINAL ASSY, REV, RIGHT

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·May 4, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    RICKHAM RESERVOIR

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015

    VENT RES TR RICKHAM LG BA

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015

    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