BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PYRAMESH® C Titanium Mesh

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000855673·MESH 9051350 PYRAMESH IMP 13MMX50MM RND

    PYRAMESH® C Titanium Mesh

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490484510·MESH 9051350 PYRAMESH IMP 13MMX50MM RND

    5051-350 Sensor

    FDA UDI
    Tekscan, Inc.·B97050513500·5051-350 Sensor

    PATIENT MATCHED TITANIUM ALLOY TROCHLEA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STARBAND CRANIAL ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JEY·April 10, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 2, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012