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    COBAS 4800 CT / NG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    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

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821109230·FORCEPS, DRESSING, DENTAL

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028690·COPPER NITI 35 BAF 17X025LO SM PK10

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819513·Deaver Blade Large 1" x 5"

    KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCORDE CURVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·April 11, 2014

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 15, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·December 23, 2013

    VA LOCKSCR Ø2.4 SELF-TAP L14 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 3, 2014

    PRISMAFLEX

    FDA Adverse Event
    GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·August 13, 2012