BEUDAMED
    29 results · 23ms · Sources: EU EUDAMED, US FDA

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    SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964070488·Endo Carry-On Procedure Kit

    Oticon

    FDA UDI
    Oticon A/S·05707131160119·SAFARI 600, BTE DBL

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971239·

    CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

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

    OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 8, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    Widex

    FDA UDI
    Widex A/S·05706069721782·Widex UNIQUE U-FS BTE (Tan silk S-330 ) Telecoi...

    Widex

    FDA UDI
    Widex A/S·05706069721256·Widex BEYOND B-F2 (Tan silk S-330 ) Telecoil, R...

    Widex

    FDA UDI
    Widex A/S·05706069722482·Widex D-PA BTE (Tan silk S-330 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069726985·Widex EVOKE E-PA (Tan silk S-330 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069722109·Widex D-FS BTE (Tan silk S-330 ) Telecoil, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069720976·Widex UNIQUE U-PA BTE (Tan silk S-330 ) RC coil

    MOTOCLIP

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code JDR·September 29, 2022

    POLYHESIVE RETURN ELECTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·May 1, 2013

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DIP·September 19, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 10, 2011

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 15, 2022

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011