BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    DILUENT, CELLENT BLOOD

    FDA 510(k)
    FDA Class 1 ·Hematology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00887517010643·RELINE-C Caliper, Cross Connector

    TRUMPF MEDICAL

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761990357·Table top segment Carbon 600 V

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989051001·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 28

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196464·AK3 Patella Resection Guide w/ Offset

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    CPK - ISOENZYMES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNO 30

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

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code JDQ·May 5, 2014

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 26, 2007

    ACCOLADE SR SL MRI (Model L310)

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