Medical Device Manufacturer · US , Rockland , MA

Smiths Medical Asd, Inc.

52 submissions · 52 cleared · Since 2004
52
Total
52
Cleared
0
Denied

Smiths Medical Asd, Inc. — FDA 510(k) Submissions

Smiths Medical Asd, Inc. has submitted 52 FDA 510(k) premarket notifications since 2004, of which 52 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube Tracheostomy And Tube Cuff, Needle, Hypodermic, Single Lumen, System, Thermal Regulating, Needle, Conduction, Anesthetic (w/wo Introducer), Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

52 devices
1–25 of 52
Hypodermic Needle-Pro? EDGE? Safety Device with Low Dead Space Syringe
K232943 · QNQ Low Dead Space Piston... · General Hospital
May 2024 254d
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
K210833 · JOH Tube Tracheostomy And... · Anesthesiology
Nov 2021 252d
Hypodermic Needle-Pro EDGE Safety Device
K211634 · FMI Needle, Hypodermic,... · General Hospital
Aug 2021 91d
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA Set, Administration,... · General Hospital
Sep 2020 385d
Level 1 Convective Warmer
K181699 · DWJ System, Thermal Regulating · Cardiovascular
Jul 2018 29d
Portex? Lancet Point Spinal Needles with NRFit? connectors, Portex? Pencil Point Spinal Needles with NRFit? connectors
K172800 · MIA Needle, Spinal, Short Term · Anesthesiology
Jun 2018 269d
Portex NRFit Epidural Needles
K172823 · BSP Needle, Conduction,... · Anesthesiology
Jun 2018 267d
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
K172410 · BSP Needle, Conduction,... · Anesthesiology
Jun 2018 296d
CADD Yellow High Volume Administration Set with NRFit connector
K172592 · PWH Administrations Sets With... · General Hospital
May 2018 261d
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
K173912 · JOH Tube Tracheostomy And... · Anesthesiology
May 2018 137d
EchoGlo Needle
K171968 · BSP Needle, Conduction,... · Anesthesiology
Jan 2018 209d
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K170720 · JOH Tube Tracheostomy And... · Anesthesiology
Dec 2017 273d
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
K172458 · DRS Transducer,... · Cardiovascular
Nov 2017 87d
CADD? Infusion Disposables Portfolio with NRFit? connectors
K162219 · PWH Administrations Sets With... · General Hospital
Jul 2017 346d
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
K163172 · DRS Transducer,... · Cardiovascular
May 2017 191d
ViaValve Safety I.V. Catheter
K160235 · FOZ Catheter, Intravascular,... · General Hospital
Jun 2016 150d
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
K141193 · PHC Infusion Safety... · General Hospital
Jul 2014 78d
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · MEA Pump, Infusion, Pca · General Hospital
Dec 2013 297d
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K111275 · FRN Pump, Infusion · General Hospital
Feb 2013 637d
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K110053 · CAZ Anesthesia Conduction Kit · Anesthesiology
Sep 2012 616d
PERIFUSE CATHETER
K121525 · CAZ Anesthesia Conduction Kit · Anesthesiology
Aug 2012 71d
VIAVALVE SAFETY IV CATHETER
K113700 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2012 89d
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K092256 · BTT Humidifier, Respiratory... · Anesthesiology
Oct 2010 449d
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · LJT Port & Catheter,... · General Hospital
Mar 2010 119d
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657 · CAZ Anesthesia Conduction Kit · Anesthesiology
Nov 2009 68d
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