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    Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. ''9-DEL-5F-180/60'' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. Manufactured in USA, Sterile EO. Headquarters AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 U.S.A. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·October 2, 2006

    VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Recall
    Terminated ·Del Medical, Inc.·Product code IXY·December 3, 2015

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Recall
    Terminated ·Del Medical, Inc.·Product code IXY·December 3, 2015

    Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code NKB·April 14, 2008

    Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. The device is used for X-Ray tube positioning.

    FDA Recall
    Terminated ·Del Medical Systems Group·Product code IYB·January 12, 2009

    Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553

    FDA Recall
    Terminated ·Del Laboratories Inc.·Product code EFW·June 9, 2005

    DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.

    FDA Recall
    Terminated ·Del Medical Systems Group·Product code IYB·February 13, 2004

    DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)

    FDA Recall
    Terminated ·Del Medical Systems Group·Product code IZL·October 3, 2006

    Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131

    FDA Recall
    Terminated ·Del Medical Systems Group·Product code IYB·March 10, 2005

    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code BTA·February 8, 2016

    MicroAire PAL Cannula Product Usage - Power Aspiration Device

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code GEA·February 8, 2016

    Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code QDI·January 18, 2022

    Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code MNI·August 21, 2008

    REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·August 6, 2008

    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code MNI·April 14, 2008

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004