Company ยท US
Smiths Medical MD, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2012. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
70recalls (0 in 12 months)
70recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 41 |
| FRN | Pump, Infusion | 16 |
| MMP | Cover, Barrier, Protective | 12 |
| LZG | Pump, Infusion, Insulin | 10 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 5 |
| MRZ | Accessories, Pump, Infusion | 3 |
| DYB | Introducer, Catheter | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| MEA | Pump, Infusion, Pca | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2012 | K112407 | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS Smiths Medical MD, Inc. | DYB |
| Aug 29, 2011 | K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc. | FRN |
| Aug 3, 2010 | K101180 | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, Smiths Medical MD, Inc. | FPA |
| Jun 12, 2009 | K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS Smiths Medical MD, Inc. | MRZ |
| Dec 17, 2008 | K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE Smiths Medical MD, Inc. | MRZ |
| Jul 18, 2008 | K081156 | CADD MEDICATION CASSETTE RESERVOIR Smiths Medical MD, Inc. | FPA |
| Apr 25, 2008 | K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP Smiths Medical MD, Inc. | FRN |
| Mar 7, 2008 | K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR Smiths Medical MD, Inc. | MEA |
| Feb 13, 2008 | K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) Smiths Medical MD, Inc. | MRZ |
| Dec 14, 2007 | K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS Smiths Medical MD, Inc. | LJT |
| Nov 1, 2007 | K072059 | GRIPPER MICRO NEEDLE Smiths Medical MD, Inc. | FMI |
| May 23, 2007 | K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE Smiths Medical MD, Inc. | LJT |
| Nov 29, 2006 | K062592 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE Smiths Medical MD, Inc. | FRN |
| Nov 1, 2006 | K062323 | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 Smiths Medical MD, Inc. | LZG |
| May 17, 2006 | K060036 | PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER Smiths Medical MD, Inc. | LJT |
| Nov 17, 2005 | K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP Smiths Medical MD, Inc. | FRN |
| Oct 7, 2004 | K042172 | CLEO 90 INFUSION SET Smiths Medical MD, Inc. | FPA |
| May 27, 2004 | K031738 | SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER Smiths Medical MD, Inc. | LZG |
| May 19, 2004 | K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc. | FPA |
| Jan 23, 2004 | K033686 | PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM Smiths Medical MD, Inc. | LJT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2009 | Smiths Medical MD, Inc. CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO.
CADD Medication Cassette Reservoirs are intended for use with the CADD Amb Terminated |
FPA | K843772 |
| Apr 16, 2009 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software.
Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is u Terminated |
LZG | K062323 |
| Apr 16, 2009 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1800.
Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare pa Terminated |
LZG | K062323 |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | K040899 |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | K040899 |
| Sep 23, 2008 | Smiths Medical MD, Inc. Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.
Reorder number 21-5311-01
The product is used for gene Terminated |
FRN | K940446 |
| Sep 23, 2008 | Smiths Medical MD, Inc. Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.
Reorder numbers 21-5301-01 & 21-5306-01
The product is us Terminated |
FRN | K940446 |
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1800.
This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and Terminated |
LZG | K020655 K031738 +1 |
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1700.
A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes.
Reorder Numbers:
21-1701-02/32/33/36/44/49/51/54/6 Terminated |
LZG | K020655 K031738 |
| Aug 24, 2008 | Smiths Medical MD, Inc. CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication.
Reorder Numbers Terminated |
FRN | K051568 |
| Aug 15, 2008 | Smiths Medical MD, Inc. CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care p Terminated |
FRN | K051568 |
| Aug 15, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112.
This Pump is similar to the currently distributed Deltec Cosmo Insulin Terminated |
LZG | K062323 |
| Aug 15, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous I Terminated |
LZG | K020655 K031738 +1 |
| Feb 26, 2008 | Smiths Medical MD, Inc. Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator
REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA Terminated |
FRN | K062892 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FPA | K040636 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC
4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 5 Terminated |
FPA | K843772 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC
4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 Terminated |
FPA | K843772 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, M Terminated |
FPA | K843772 |
| Apr 26, 2007 | Smiths Medical MD, Inc. Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096 Terminated |
FRN | K982640 |
| Apr 5, 2007 | Smiths Medical MD, Inc. Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD Terminated |
FRN | K000842 K960826 +1 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | K992880 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Poly Terminated |
MMP | K871132 K931073 +1 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | K942024 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Si Terminated |
MMP | K871132 K932841 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | K992880 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po Terminated |
MMP | K871132 K931073 +1 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane C Terminated |
MMP | K871132 K931073 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane C Terminated |
MMP | K871132 K931073 +1 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, n Terminated |
FPA | K811933 K991599 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, Terminated |
FPA | K811933 K991599 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary ( Terminated |
FPA | K811933 K991599 |
| Feb 26, 2005 | Smiths Medical MD, Inc. Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Terminated |
LZG | K020655 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC1201 (Reorder No. 21-0442-25) Primary Checkvalve Admini Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC2124 (Reorder No. 21-0441-25) Specialty Administration Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Se Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C4240J (Reorder No. 21-0352-25) Specialty Administratio Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C825 (Reorder No. 21-0347-25) Specialty Administration Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration Se Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C4209 (Reorder No. 21-0327-01) Primary one-way Checkvalv Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ2304 (Reorder No. 21-0433-01) Burette Administration Se Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NC1301 (Reorder No. 21-0428-01) Primary Checkvalve for Se Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NK4303 (Reorder No. 21-0427-01) described as 110 inch len Terminated |
FPA | K811933 K896161 +1 |
| Feb 2, 2005 | Smiths Medical MD, Inc. Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch len Terminated |
FPA | K811933 K896161 +1 |
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