FDA 510(k) Applications Submitted by JASON SMITH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060093 |
01/12/2006 |
PRESEP OLIGON OXIMETRY CATHETERS |
EDWARDS LIFESCIENCES, LLC. |
| K030944 |
03/26/2003 |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
| K001063 |
04/03/2000 |
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 |
BAXTER HEALTHCARE CORP. |
| K091709 |
06/10/2009 |
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC |
EDWARDS LIFESCIENCES, LLC. |
| K131958 |
06/27/2013 |
BAUSCH & LOMB INJECTOR SYSTEM |
BAUSCH & LOMB |
| K062134 |
07/26/2006 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
| K992532 |
07/29/1999 |
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING |
BAXTER HEALTHCARE CORP. |
| K132481 |
08/08/2013 |
EASY-LOAD LENS DELIVERY SYSTEM |
BAUSCH & LOMB |
| K082308 |
08/13/2008 |
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
| K033250 |
10/07/2003 |
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR |
EDWARDS LIFESCIENCES, LLC. |
| K033463 |
10/31/2003 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE |
EDWARDS LIFESCIENCES LLC. |
| K033464 |
10/31/2003 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE |
EDWARDS LIFESCIENCES LLC. |
| K964373 |
11/01/1996 |
SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT |
3M HEALTH CARE |
| K964374 |
11/01/1996 |
SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT |
3M HEALTH CARE |
| K043065 |
11/05/2004 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P |
EDWARDS LIFESCIENCES, LLC. |
| K123736 |
12/05/2012 |
CRYSTALSERT DELIVERY SYSTEM |
BAUSCH & LOMB |
| K014052 |
12/10/2001 |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
| K014054 |
12/10/2001 |
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
| K113852 |
12/29/2011 |
BAUSCH & LOMB IOL INJECTOR |
BAUSCH & LOMB, INC. |
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