BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479010801·GRADIA PLUS Paste HB-PE, 3.3ml, 1pc

    Venner™ PneuX P.Y.™ ETT

    FDA UDI
    VENNER MEDICAL (SINGAPORE) PTE. LTD.·08885009190738·The Venner™ PneuX P.Y.™ Endotracheal tube is de...

    AXIAL RING HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929010800·AXIAL HANDLE WITH SPREADING SPRING

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112342·SURG-I-BAND ORANGE GLOW

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024201958·

    SEALED CALL CORD, 8-PIN DIN, 8FT

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828131391·SEALED CALL CORD, 8-PIN DIN, 8FT

    SEALED CALL CORD, 8-PIN DIN, 8FT

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828131407·SEALED CALL CORD, 8-PIN DIN, 8FT

    SPINE SYSTEM EVOLUTION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX

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

    Sterile neuroprobe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290114061957·

    NeuroProbe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290014954557·

    NeuroProbe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290016450552·

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·April 23, 2019

    PROMUS ELEMENT ? LONG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 30, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 8, 2013

    ENDO STITCH SURGIDAC 2/0 7 GRN DLU TU

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code KOG·November 10, 2010

    Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, for spinal fixation.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007

    TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877

    FDA Enforcement
    Class II ·Terminated·Acclarent, Inc.·January 29, 2020

    TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

    FDA Enforcement
    Class II ·Terminated·Acclarent, Inc.·January 29, 2020