FDA 510(k) Applications Submitted by SMITHS MEDICAL ASD, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070340 |
02/06/2007 |
SECURE ARTERIAL BLOOD SAMPLING SYSTEM |
SMITHS MEDICAL ASD, INC. |
| K071269 |
05/07/2007 |
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM |
SMITHS MEDICAL ASD, INC. |
| K081440 |
05/22/2008 |
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
| K072419 |
08/28/2007 |
ADVANTIV SAFETY I.V. CATHETER |
SMITHS MEDICAL ASD, INC. |
| K160235 |
02/01/2016 |
ViaValve Safety I.V. Catheter |
SMITHS MEDICAL ASD, INC. |
| K061194 |
04/28/2006 |
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 |
SMITHS MEDICAL ASD, INC. |
| K081229 |
04/30/2008 |
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING |
SMITHS MEDICAL ASD, INC. |
| K071785 |
07/02/2007 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE |
SMITHS MEDICAL ASD, INC. |
| K072482 |
09/04/2007 |
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY |
SMITHS MEDICAL ASD, INC. |
| K072783 |
10/01/2007 |
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH |
SMITHS MEDICAL ASD, INC. |
| K073188 |
11/13/2007 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE |
SMITHS MEDICAL ASD, INC. |
| K063450 |
11/15/2006 |
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 |
SMITHS MEDICAL ASD, INC. |
| K113700 |
12/16/2011 |
VIAVALVE SAFETY IV CATHETER |
SMITHS MEDICAL ASD, INC. |
| K063755 |
12/19/2006 |
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE |
SMITHS MEDICAL ASD, INC. |
| K041399 |
05/26/2004 |
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE |
SMITHS MEDICAL ASD, INC. |
| K163172 |
11/14/2016 |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
SMITHS MEDICAL ASD, INC. |
| K121525 |
05/23/2012 |
PERIFUSE CATHETER |
SMITHS MEDICAL ASD, INC. |
| K071958 |
07/16/2007 |
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS |
SMITHS MEDICAL ASD, INC. |
| K083336 |
11/12/2008 |
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL |
SMITHS MEDICAL ASD, INC. |
| K110053 |
01/07/2011 |
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT |
SMITHS MEDICAL ASD, INC. |
| K090261 |
02/03/2009 |
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G |
SMITHS MEDICAL ASD, INC. |
| K092657 |
08/28/2009 |
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E |
SMITHS MEDICAL ASD, INC. |
| K051524 |
06/08/2005 |
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 |
SMITHS MEDICAL ASD, INC. |
| K062005 |
07/17/2006 |
PORTEX EPIDURAL CATHETER |
SMITHS MEDICAL ASD, INC. |
| K072080 |
07/30/2007 |
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, |
SMITHS MEDICAL ASD, INC. |
| K083451 |
11/21/2008 |
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS |
SMITHS MEDICAL ASD, INC. |
| K083641 |
12/09/2008 |
BIVONA TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
| K050314 |
02/09/2005 |
AQUINOX |
SMITHS MEDICAL ASD, INC. |
| K211634 |
05/27/2021 |
Hypodermic Needle-Pro EDGE Safety Device |
Smiths Medical ASD, Inc. |
| K181699 |
06/27/2018 |
Level 1 Convective Warmer |
Smiths Medical ASD, Inc. |
| K173912 |
12/22/2017 |
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 Trache |
Smiths Medical ASD, Inc. |
| K170720 |
03/09/2017 |
Portex Blue Line Ultra Paediatric Tracheosomy Tube |
Smiths Medical ASD, Inc. |
| K081086 |
04/16/2008 |
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 |
SMITHS MEDICAL ASD, INC. |
| K083031 |
10/10/2008 |
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT |
SMITHS MEDICAL ASD, INC. |
| K083119 |
10/22/2008 |
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 |
SMITHS MEDICAL ASD, INC. |
| K111275 |
05/06/2011 |
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE |
SMITHS MEDICAL ASD, INC. |
| K171968 |
06/30/2017 |
EchoGlo Needle |
Smiths Medical ASD, Inc. |
| K172410 |
08/09/2017 |
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 |
Smiths Medical ASD, Inc. |
| K172592 |
08/29/2017 |
CADD Yellow High Volume Administration Set with NRFit connector |
Smiths Medical ASD, Inc. |
| K172800 |
09/18/2017 |
Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
| K172458 |
08/14/2017 |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
Smiths Medical ASD, Inc. |
| K210833 |
03/19/2021 |
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
Smiths Medical ASD, Inc. |
| K092256 |
07/28/2009 |
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 |
SMITHS MEDICAL ASD, INC. |
| K130394 |
02/15/2013 |
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 |
SMITHS MEDICAL ASD, INC. |
| K093414 |
11/02/2009 |
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS |
SMITHS MEDICAL ASD, INC. |
| K172823 |
09/18/2017 |
Portex NRFit Epidural Needles |
Smiths Medical ASD, Inc. |
| K061513 |
06/01/2006 |
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET |
SMITHS MEDICAL ASD, INC. |
| K141193 |
05/08/2014 |
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 |
SMITHS MEDICAL ASD, INC. |
| K040632 |
03/10/2004 |
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 |
SMITHS MEDICAL ASD, INC. |
| K192375 |
08/30/2019 |
Intellifuse Administration and Intellifuse Blood Administration Sets |
Smiths Medical ASD, Inc. |
| K162219 |
08/08/2016 |
CADD« Infusion Disposables Portfolio with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
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