BEUDAMED
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    KINSA SMART THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000356·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000349·

    NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AC APPLICATOR, AURORA AC

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164516·L Ultracongruent Tibial Insert Trial with Anter...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144679·L CR UHMWPE Ultracongruent Tibial Insert Sz C 14mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102044·L CR MAXTM HXL Ultracongruent Tibial Insert Sz ...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124268·L Ultracongruent Tibial Insert Trial Sz C 14mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101184·L CR E-MAXTM Vitamin E Ultracongruent Tibial In...

    CAPITAL BLOOD/FLUID WARMER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code KZL·May 29, 2013

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011

    CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·October 1, 2014

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024