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    18 GAUGE TRU-CUT BIOPSY NEEDLE

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

    Nexxis OR

    FDA UDI
    Barco NV·05415334034891·NEXXIS SYSTEM X670 CM V4

    Eye Shield

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111178·EYE SHIELD CLEAR PLASTIC PACK OF 12

    Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube

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

    PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

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

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 24, 2014

    OXIMAX N-560 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·January 24, 2013

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·January 13, 2011

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008