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

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    THE DOUBLE GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 30mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020717·

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435012716·Plate holding forceps curved 18 cm

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930706003000·Custom Wing Blade 30mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400600300·Anterior Dome Osteotomy Guide, 60mm x 30mm

    Canaveral®

    FDA UDI
    FLOSPINE LLC·B183120600300·6.0mm Curved Rod, Ti Alloy 30mm

    LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 19, 2013

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·June 12, 2008

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FAD·September 9, 2020

    PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    FDA Enforcement
    Class II ·Terminated·Valorem Surgical LLC·August 16, 2017

    CONFIDENCE KIT, NO NEEDLES

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FAD·September 9, 2020

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS TAQMAN HCV TEST VERSION 2.0

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM