FDA 510(k) Applications Submitted by JAMES C LANE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050256 |
02/03/2005 |
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
| K030588 |
02/25/2003 |
ARTEGRAL AND POLYSTAR SELECTION |
MERZ DENTAL GMBH |
| K000724 |
03/06/2000 |
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 |
MEDICA S.R.L. |
| K991895 |
06/03/1999 |
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) |
RI MOS. S.R.L. |
| K071587 |
06/11/2007 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY |
INVERNESS MEDICAL INNOVATIONS, INC. |
| K061933 |
07/07/2006 |
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER |
HAGER WORLDWIDE, INC. |
| K983037 |
08/31/1998 |
ROEKO SEAL |
ROEKO ULM, ROESCHEISEN GMBH & CO. |
| K973539 |
09/18/1997 |
ROEKO CALCIUM HYDROXIDE POINTS |
ROEKO USA, INC. |
| K003219 |
10/16/2000 |
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST |
HARALD NORDIN S.A |
| K003221 |
10/16/2000 |
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST |
HARALD NORDIN S.A |
| K043322 |
12/02/2004 |
MIRAMATIC SAFE SYRINGE SYSTEM |
HAGER WORLDWIDE, INC. |
| K970696 |
02/25/1997 |
S.P. 100 |
LSI INTL., INC. |
| K984021 |
11/12/1998 |
MS300 |
LSI INTL., INC. |
| K984113 |
11/17/1998 |
MS400 |
LSI INTL., INC. |
| K002390 |
08/04/2000 |
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H |
LSI INTL., INC. |
| K060133 |
01/18/2006 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET |
INVERNESS MEDICAL INNOVATIONS, INC. |
| K020587 |
02/22/2002 |
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 |
PULSION MEDICAL SYSTEMS AG |
| K011310 |
04/30/2001 |
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 |
NIEN MADE ELECTRNICS CORP. |
| K053196 |
11/16/2005 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) |
INVERNESS MEDICAL INNOVATIONS, INC. |
| K993950 |
11/22/1999 |
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 |
NIEN MADE ELECTRNICS CORP. |
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