BEUDAMED
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    ECG SERIES ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213022324·Flexitron Transfer Tube Set for Metal Needles (...

    311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260864·

    GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDROFIX VASO SHIELD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRIVER; SIZE 10

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

    Q2 MULTIPORT MANIFOLD EXTENSION LINE

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code FPA·May 7, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Depuy LCS Complete RP insert; polyethylene tibial insert MED, 15 mm; Ref 1294-05-315.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014