BEUDAMED
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    SPECIMEN RETRIEVAL SYSTEM

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

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    Pro-Flo XT™

    FDA UDI
    MEDTRONIC, INC.·00613994944603·CATH 060051 PF 10PK 6F XT SF TP JL 4 125

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813290·Tissue Forceps, Fine, Smooth, 16cm

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450055502·

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0600110·Tray Insert, ISP, Implant

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600010·Tray Insert, Level 1

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0600010·Tray Insert 1, Ocata

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600110·Tray Insert, Lumbar Instruments, 3

    Medfusion

    FDA UDI
    ICU MEDICAL, INC.·10610586043291·

    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTICOAT FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    S5 CONTROL PANEL

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012