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    OROPHARYNGEAL SUCTION AIRWAY

    FDA 510(k)
    FDA Class 1 ·Dental

    Site~Rite 8 Ultrasound System

    FDA UDI
    Bard Access Systems, Inc.·00801741138263·Site~Rite 8 Ultrasound System Console

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551198513·Handle, with central screw connection

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515087460·Mini Hohmann Retr, 6mm blade width, 6 1/2"

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515199804·Mini Hohmann Retr, 6mm blade width, 6 1/2"

    NA

    FDA UDI
    aap Implantate AG·04042409210365·Large handle, cannulated, quick coupling

    CARTO 3 EP Navigation System, Version 6.0 and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIAC OUTPUT COMPUTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code IYO·September 21, 2018

    SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code IYO·August 30, 2018

    SITE~RITE 8 ULTRASOUND SYSTEM, US

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code IYO·August 23, 2018

    COMMON NAME PROSTHESIS, RIB REPLACEMENT

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MDI·April 24, 2014

    ACCU-CHEK AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 25, 2007

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2012

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 4, 2019

    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).

    FDA Recall
    Terminated ·Pelstar, Llc·Product code FRI·October 7, 2011

    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code IYO·November 4, 2019