BEUDAMED
    24 results · 33ms · Sources: EU EUDAMED, US FDA

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    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    FDA Recall
    Terminated ·X Spine Systems Inc·Product code MNH·April 7, 2015

    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    FDA Enforcement
    Class II ·Terminated·X Spine Systems Inc·July 1, 2015

    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·September 26, 2018

    Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

    Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

    Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.

    FDA Recall
    Terminated ·Portex, Inc·Product code KOH·February 20, 2003

    Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090

    FDA Recall
    Terminated ·Portex Inc.·Product code BTO·June 18, 2003

    Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20

    FDA Recall
    Terminated ·Portex Inc·Product code CAZ·October 10, 2003

    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm Reference Number: 100/111/035

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference Number: 100/111/030

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm Reference Number: 100/111/080

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19cm Reference Number: 100/126/060

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference Number: 100/105/050

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5 mm x 19cm Reference Number: 100/127/035

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye 8 mm x 33cm Reference Number: 100/199/080

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8503P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002