BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    OXYGENATOR

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

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019829·Endo Carry-On Procedure Kit

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026320·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 13, 2013

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·February 28, 2011

    DAR

    FDA Adverse Event
    Death ·MIRANDOLA - DAR·Product code CAH·February 26, 2008

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022