FDA 510(k) Applications Submitted by DAVID L WEST
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K973510 |
09/16/1997 |
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) |
IMMUNO-U.S., INC. |
| K965034 |
12/17/1996 |
SORBASTACE |
HEMOSTACE LLC. |
| K120412 |
02/10/2012 |
3M SPOTON TEMPERATURE MONITORING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K060865 |
03/30/2006 |
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 |
ARIZANT HEALTHCARE INC. |
| K060939 |
04/06/2006 |
RANGER IRRIGATION FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K041686 |
06/22/2004 |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
ARIZANT HEALTHCARE INC. |
| K082217 |
08/06/2008 |
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K053645 |
12/30/2005 |
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS |
ARIZANT HEALTHCARE INC. |
| K010424 |
02/13/2001 |
NEXAN SYSTEM, MODEL NX-301 |
NEXAN LTD |
| K970650 |
02/20/1997 |
ASAHI AM-R SERIES DIALYZERS |
ASAHI MEDICAL CO., LTD. |
| K981390 |
04/16/1998 |
ODONTOSURGE 2 |
PERIOGIENE |
| K001250 |
04/19/2000 |
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) |
ASAHI MEDICAL CO., LTD. |
| K991512 |
04/30/1999 |
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X |
ASAHI MEDICAL CO., LTD. |
| K051187 |
05/09/2005 |
REXEED SERIES DIALYZERS |
ASAHI KASEI MEDICAL CO., LTD. |
| K041726 |
06/25/2004 |
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX |
ASAHI MEDICAL CO., LTD. |
| K082515 |
09/02/2008 |
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX |
ASAHI KASEI MEDICAL CO., LTD. |
| K013418 |
10/15/2001 |
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY |
ASAHI MEDICAL CO., LTD |
| K983720 |
10/21/1998 |
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- |
ASAHI MEDICAL CO., LTD. |
| K003520 |
11/15/2000 |
NEXAN SYSTEM, MODEL NX-300 |
NEXAN LTD |
| K004050 |
12/29/2000 |
PANASONIC TELE-HOMECARE SYSTEM |
MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. |
|
|
