BEUDAMED
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    EK/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EK/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PENTAX Medical EKP-i5010 Video Processor with EB Family

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 8, 2010

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 12, 2023

    DAILIES TOTAL 1 MULTIFOCAL

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code LPL·June 8, 2018

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 6, 2010

    K-REAMER M-ACCESS 21MM 020

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKP·July 29, 2024

    K-REAMER

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKP·February 15, 2013

    PATTERSON BRAND CONTRA ANGLE REAMER

    FDA Adverse Event
    Malfunction ·PATTERSON DENTAL CO.·Product code EKP·June 30, 2005

    PATTERSON BRAND CONTRA ANGLE REAMER

    FDA Adverse Event
    Malfunction ·PATTERSON DENTAL CO.·Product code EKP·June 30, 2005

    GATES GLIDDEN DRILL #4

    FDA Adverse Event
    LES FILS D'AUGUSTE MAILLEFER S.A.·Product code EKP·September 8, 2004

    PEESO-ENLARGERS C.A.

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKP·November 2, 2018

    K-REAMER M-ACCESS 21MM 015

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKP·August 8, 2023

    K-REAMER M-ACCESS 21MM 020

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKP·July 9, 2025

    K-REAMER M-ACCESS 25MM 015

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKP·April 16, 2024

    GATES AD 32MM 3

    FDA Adverse Event
    Malfunction ·TULSA DENTAL PRODUCTS LLC·Product code EKP·May 28, 2024

    K-REAMER

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKP·January 6, 2017

    K-REAMER

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKP·January 6, 2017

    K-REAMER

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKP·January 6, 2017