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

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    ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ICE BATON

    FDA 510(k)
    FDA Unclassified ·Unknown

    VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 23, 2008

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·April 28, 2011

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    INFERIOR END PLATE LARGE-STERILE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·June 22, 2016

    AVAN TAP CORT SCR SS 4.5X26MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X58MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X48MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X56MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X20MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019