BEUDAMED
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    FIBERSCOPE DISINFECTANT IRRIGATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780118466·The locking rearfoot screw is used in the Integ...

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838860·3.5MM PLATE LOCKING SCREW 26MM

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591011024·Neoprene Hinged Knee Wrap, Large

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707028390·WEB 1ST MOLAR BANDS n.UL 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88300261·Max. 1. Molar band W-Fit right 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88300260101·Max. 1. Molar band W-Fit right 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88300260501·Max. 1. Molar band W-Fit right 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88300260051·Max. 1. Molar band W-Fit right 26

    REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SQUALE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·COSMOS(TM) SYSTEM

    INRATIO/INRATIO2 TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·March 13, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 13, 2012

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 10, 2015

    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·February 5, 2020

    MELODY TRANSCATHETER PULMONARY VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·April 11, 2018

    VALVE CONTEGRA

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code MWH·April 11, 2018

    HANCOCK PULMONIC CONDUIT

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 11, 2018

    MELODY TRANSCATHETER PULMONARY VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·April 11, 2018