BEUDAMED
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    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236016920·Overdenture Caps Assortment Kit (2 pack)

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236012519·ODSecure Assortment Kit (2 pack)

    CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APTIO

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGANOSTICS INC.·Product code JJE·November 17, 2016

    CENTRISOL CA 0.0, K 0.0

    FDA Adverse Event
    Injury ·MINNTECH·Product code KPO·February 20, 2014

    COMPACT SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND GMBH·Product code DTQ·August 13, 2015

    DIMENSION VISTA 1500

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·January 15, 2016

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·Ge Healthcare·Product code RCC·May 8, 2020

    BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION GLENOID COMPO

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·October 27, 2006

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·Ge Healthcare·September 9, 2020

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 18, 2006

    DIMENSION VISTA 1500

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 18, 2014

    NATRUAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSH·December 12, 2007

    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·July 30, 2014

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 11, 2023

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CEM·October 7, 2011

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 7, 2011

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 7, 2011

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 7, 2011

    ABL800 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·March 28, 2022