BEUDAMED
    103 results · 12ms · Sources: EU EUDAMED, US FDA

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    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.

    FDA Enforcement
    Class II ·Terminated·Utah Medical Products, Inc·November 18, 2015

    Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·May 28, 2014

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·July 15, 2015

    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

    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

    FDA Enforcement
    Class II ·Terminated·Epimed International·November 15, 2017

    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

    FDA Enforcement
    Class I ·Terminated·Tytek Medical Inc·February 19, 2020

    Arrow central venous catheterization kit, 14 ga x 20 cm

    FDA Recall
    Terminated ·Arrow International Inc·Product code KZH·September 16, 2003

    Arterial Catheterization Set

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·July 29, 2010

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Enforcement
    Class II ·Terminated·Medisystems a NX Stage Company·January 30, 2013

    Femoral Artery Catheterization Set

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·July 29, 2010

    Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 15, 2005

    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·July 29, 2010

    Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·July 29, 2010

    Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·July 29, 2010

    Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·July 29, 2010

    CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·October 10, 2018

    Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code KZH·March 8, 2005

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015

    MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters

    FDA Recall
    Terminated ·Arrow International Inc·Product code DYB·July 29, 2010

    Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·July 29, 2010