BEUDAMED
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    VITEK 2 GRAM POSITIVE VANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015

    ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

    FDA 510(k)
    FDA Class 2 ·Hematology

    RAICHEM GLUCOSE UV REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERCISE GEVIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·August 18, 2020

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 3, 2021

    CRS FAST SET PUTTY 10CC BONE CEMENT-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code MQV·April 23, 2013

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

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