BEUDAMED
    200 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical Asd Inc·June 17, 2015

    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

    CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·September 6, 2017

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    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

    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    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

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·November 27, 2024

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024