BEUDAMED
    21 results · 10ms · Sources: EU EUDAMED, US FDA

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    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Enforcement
    Class II ·Terminated·Z-Medica, LLC·June 28, 2017

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Recall
    Terminated ·Z-Medica, LLC·Product code FRO·May 17, 2017

    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BYZ·November 4, 2013

    HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids.

    FDA Recall
    Terminated ·Haemacure Corporation·Product code KYZ·November 16, 2009

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KYZ·February 6, 2018

    ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385. Distributed by Lifebond, P.O. Box 3048 Caesarea Industrial Park 38900, Israel, LP-AP-M0001, LifeSeal SLR Applicator Sterilized by Ethylene Oxide, Manufactured By Micromedics, St Paul, MN 55121-1385 USA.

    FDA Recall
    Terminated ·Micromedics, Inc.·Product code KYZ·March 15, 2010

    BARD Piston Syringe, 60cc, Rx Only, Sterile, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KYZ·August 3, 2016

    Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.

    FDA Recall
    Terminated ·Shippert Medical Technologies·Product code KYZ·June 1, 2017

    Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.

    FDA Recall
    Terminated ·Medtronic Neurosurgery·Product code KYZ·June 28, 2013

    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Recall
    Terminated ·Cook Inc.·Product code KYZ·December 19, 2017

    BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KYZ·August 3, 2016

    Irrigation Tray w/Bulb syringe, catalog# 900-020

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KYZ·December 8, 2011

    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KYZ·January 7, 2016

    IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KYZ·July 10, 2015

    Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.

    FDA Recall
    Terminated ·Shippert Medical Technologies·Product code KYZ·June 1, 2017

    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KYZ·January 4, 2016

    BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KYZ·August 3, 2016

    AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS700-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA

    FDA Recall
    Terminated ·Micromedics, Inc.·Product code KYZ·March 15, 2010

    BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KYZ·August 3, 2016

    Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.

    FDA Recall
    Terminated ·Med Tec Inc·Product code JAI·November 8, 2017