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Smiths Medical Asd, Inc.

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

Total Devices16
Categories10
Latest FDA decision2024-05-31
TypeNumberDevice NameCodeDateActions
510(k) K232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeQNQ2024-05-31 View
510(k) K210833 Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaJOH2021-11-26 View
510(k) K211634 Hypodermic Needle-Pro EDGE Safety DeviceFMI2021-08-26 View
510(k) K192375 Intellifuse Administration and Intellifuse Blood Administration SetsFPA2020-09-18 View
510(k) K181699 Level 1 Convective WarmerDWJ2018-07-26 View
510(k) K172800 Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsMIA2018-06-14 View
510(k) K172823 Portex NRFit Epidural NeedlesBSP2018-06-12 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 FiltersBSP2018-06-01 View
510(k) K172592 CADD Yellow High Volume Administration Set with NRFit connectorPWH2018-05-17 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 tubeJOH2018-05-08 View
510(k) K171968 EchoGlo NeedleBSP2018-01-25 View
510(k) K170720 Portex Blue Line Ultra Paediatric Tracheosomy TubeJOH2017-12-07 View
510(k) K172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitDRS2017-11-09 View
510(k) K162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsPWH2017-07-20 View
510(k) K163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitDRS2017-05-24 View
510(k) K160235 ViaValve Safety I.V. CatheterFOZ2016-06-30 View
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