BEUDAMED
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    CONCORDE CURVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    tremoflo C-100 Airwave Oscillometry - Support Arm

    FDA UDI
    Thorasys Thoracic Medical Systems Inc·07540261019234·Optional support arm accessory for the tremoflo...

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030214·LEGGINGS

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691035·

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·47291046346769·Rotary diamond instrument for dental application

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046111791·FG Rotary diamond instrument for dental applica...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046257970·Rotary diamond instrument for dental application

    REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NEXFIN MODEL 2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013

    ADJ PIN COLLET 2.0-3.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 18, 2011

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·August 5, 2008

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·October 29, 2019

    Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

    FDA Recall
    Terminated ·Isopure Corp·Product code N/A·April 19, 2019

    Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·January 29, 2020

    Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

    FDA Recall
    Terminated ·Isopure Corp·Product code KPO·April 19, 2019

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

    FDA Recall
    Terminated ·Isopure Corp·Product code FIN·April 19, 2019

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·January 29, 2020

    Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·January 29, 2020

    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014