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

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    i-STAT CG4+ Cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BENGOLEA HEMOSTATIC FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084827·BENGOLEA HEMOSTATIC FORCEPS CROSS-SERRATED CURV...

    Ceramitec Gorney Scissors

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896119901·Ceramitec Gorney Scissors Power Cut Straight Sh...

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981057329·Plate - 4 Level - 92 mm

    3MTM AttestTM Mini Auto-reader 490M

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MDA D-DIMER

    FDA 510(k)
    FDA Class 2 ·Hematology

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 24, 2024

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2025

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2025

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 23, 2024

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 3, 2025

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·June 20, 2018

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 1, 2013

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 9, 2024

    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.

    FDA Enforcement
    Class I ·Terminated·Ventlab LLC·July 9, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014