BEUDAMED
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    CAPILLARYS URINE

    FDA 510(k)
    FDA Class 2 ·Immunology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608297·ALLEN, STERIS-AMSCO 3" SOFTCARE

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197194778·Ferreira Style Breast Retractor 80x16 ...

    UFI GEL HARD C

    FDA 510(k)
    FDA Class 2 ·Dental

    PTW DOSIMETRY DIODE, T60008

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYRINGE 10ML SALINE XS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMF·May 10, 2019

    ACCU-CHEK LINKASSIST

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code FPA·April 26, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 7, 2011

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·July 22, 2008

    Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001

    FDA Enforcement
    Class II ·Terminated·Lumitex Inc·February 12, 2020

    Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001

    FDA Recall
    Terminated ·Lumitex Inc·Product code LBI·December 11, 2019

    Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·January 8, 2014