BEUDAMED
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    MC3 Jugular Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304439092·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868239519·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821615·Jansen Bayonet, Monopolar Hand Switching Forcep...

    Super Upper Limbs Versalock Plating System

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07901125601512·VERSALOCK RADIUS SHAFT PLATE, DORSOLATERAL HIPE...

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK

    ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277175139·

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 27, 2011

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·June 4, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

    Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

    FDA Enforcement
    Class III ·Terminated·R & D Systems, Inc.·January 9, 2019

    VARIABLE LOCK SCREW 4.75X15MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018