BEUDAMED
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    LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099563·MAN 1ST MOLAR UNIV 109 BANDS

    Single Use Surgical Optical Fiber

    FDA UDI
    QUANTA SYSTEM SPA·08033945937263·Single Use Surgical Optical Fiber ø 550 µm Dist...

    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTICOAT FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    POLY-TAPE, 20 X 500MM

    FDA Adverse Event
    Injury ·XIROS·Product code JDR·December 6, 2011

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·June 15, 2022

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013

    MEC-2000 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD·Product code MHX·August 18, 2014

    TINA-QUANT HEMOGLOBIN A1C GEN.2

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LCP·May 16, 2011

    UNK RECAP MAGNUM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·December 5, 2019

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    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