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Smiths Medical MD, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K112407SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERSFebruary 9, 2012
K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPAugust 29, 2011
K101180GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3August 3, 2010
K091181LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPSJune 12, 2009
K082783CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CAREDecember 17, 2008
K081156CADD MEDICATION CASSETTE RESERVOIRJuly 18, 2008
K080743LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMPApril 25, 2008
K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORMarch 7, 2008
K072955CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)February 13, 2008
K072657POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND PODecember 14, 2007
K072059GRIPPER MICRO NEEDLENovember 1, 2007
K070116POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUSMay 23, 2007
K062592CADD-SENTRY PRO MEDICATION SAFETY SOFTWARENovember 29, 2006
K062323DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-November 1, 2006
K060036PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYMay 17, 2006
K051568CADD-MS 3 AMBULATORY INFUSION PUMPNovember 17, 2005
K042172CLEO 90 INFUSION SETOctober 7, 2004
K031738SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METERMay 27, 2004
K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SMay 19, 2004
K033686PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEMJanuary 23, 2004