BEUDAMED
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    DUKAL LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045890·Curved Sizer, 17mm

    PLANMECA PROMAX 3D MID

    FDA 510(k)
    FDA Class 2 ·Dental

    RE-ENTRANT CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLADIATOR¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 5, 2023

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR, LLC·Product code OBR·May 1, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·May 15, 2013

    PINN MAR +4 NEUT 40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011

    The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·December 26, 2012

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025