BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

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

    VS3

    FDA UDI
    VISIONSENSE LTD.·10813040013308·VS3 Cart

    VS3-IR

    FDA UDI
    VISIONSENSE LTD.·18130400103304·VS3 Cart

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111386404·DRESSING FCP FLUTED HDL 5"

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780418757·Integra® Miltex® Lempert Elevator 7-1/4", Curve...

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191341101·IN-OVATION® mini Base Rx 018/LR4 -17T -1A 4D HK

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191341801·IN-OVATION® mini EURO 018/LR4 -12T 2A

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191341811·IN-OVATION® mini EURO 018/LR4 -12T 2A HK

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191341001·IN-OVATION® mini Base Rx 018/LR4 -17T -1A 4D

    SYNCHRON® AMYLASE (AMY) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CLEANE / CLEANE POP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    IBALANCE TKA TIBIAL TRAY SIZE 8

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code JWH·August 5, 2016

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 26, 2013

    MICRUS MICROCOIL SYSTEM

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR CORPORATION·Product code HCG·July 27, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008

    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·March 30, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022