FDA 510(k) Applications Submitted by KIM TOMPKINS, RN, MBA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140096 |
01/14/2014 |
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE |
HMICRO, INC. |
| K030742 |
03/10/2003 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYO VASCULAR SYSTEMS INC. |
| K120853 |
03/21/2012 |
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
BIONESS, INC. |
| K961900 |
05/16/1996 |
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K091924 |
06/30/2009 |
VPS CATHETER |
VASONOVA INC. |
| K172011 |
07/03/2017 |
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
HMicro, Inc. |
| K972641 |
07/15/1997 |
DUAL OFFSET PERFECTA IMC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K042230 |
08/17/2004 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
| K983104 |
09/04/1998 |
NORIAN PERIODONTAL/DENTAL CEMENT (PDC) |
NORIAN CORP. |
| K122784 |
09/11/2012 |
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
BIONESS, INC. |
| K973524 |
09/17/1997 |
ADVANCE MODULAR TIBIAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K973530 |
09/18/1997 |
INFINTY DISTAL FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K042541 |
09/20/2004 |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
| K103260 |
11/04/2010 |
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE |
VASONOVA INC. |
| K974328 |
11/18/1997 |
ADVANCE TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K033622 |
11/18/2003 |
POLARCATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
| K123636 |
11/23/2012 |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
BIONESS, INC. |
| K083920 |
12/31/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
| K103255 |
11/03/2010 |
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
VASONOVA INC. |
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