BEUDAMED
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    ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574695·CoRoent Ant TLIF Ti, 13x10x40mm 8°

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925016613·GOLDMAN CURETTE, LARGE

    LINK Instruments - Handles and adapters

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575172214·Orthopaedic prosthesis instrument, reusable - G...

    SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·September 10, 2024

    REAMER SHAFT, MOD, TRINKLE 8.0X284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012

    CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A

    FDA 510(k)
    FDA Class 2 ·Hematology

    POSTERIOR LATERAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 30, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVY·June 16, 2011

    13 CM TRICUT BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

    CURVED SINUS BURS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

    FDA Enforcement
    Class II ·Terminated·SEPPIM SAS·November 13, 2013

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015