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Smiths Medical Asd, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories10
Latest Approval2024-05-31
TypeNumberDevice NameCodeDate
510(k) K232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe QNQ 2024-05-31 View
510(k) K210833 Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula JOH 2021-11-26 View
510(k) K211634 Hypodermic Needle-Pro EDGE Safety Device FMI 2021-08-26 View
510(k) K192375 Intellifuse Administration and Intellifuse Blood Administration Sets FPA 2020-09-18 View
510(k) K181699 Level 1 Convective Warmer DWJ 2018-07-26 View
510(k) K172800 Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors MIA 2018-06-14 View
510(k) K172823 Portex NRFit Epidural Needles BSP 2018-06-12 View
510(k) K172410 Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters BSP 2018-06-01 View
510(k) K172592 CADD Yellow High Volume Administration Set with NRFit connector PWH 2018-05-17 View
510(k) K173912 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube JOH 2018-05-08 View
510(k) K171968 EchoGlo Needle BSP 2018-01-25 View
510(k) K170720 Portex Blue Line Ultra Paediatric Tracheosomy Tube JOH 2017-12-07 View
510(k) K172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit DRS 2017-11-09 View
510(k) K162219 CADD® Infusion Disposables Portfolio with NRFit™ connectors PWH 2017-07-20 View
510(k) K163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit DRS 2017-05-24 View
510(k) K160235 ViaValve Safety I.V. Catheter FOZ 2016-06-30 View