FDA 510(k) Applications Submitted by GERARD J PRUD'HOMME
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120103 |
01/12/2012 |
REST ASSURED GENERATION III DENTAL PROTECTOR |
RANIR LLC |
| K081102 |
04/17/2008 |
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
| K981533 |
04/29/1998 |
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 |
AMERICAN TELECARE, INC. |
| K131434 |
05/17/2013 |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
VISIONSENSE, LTD. |
| DEN100016 |
05/21/2010 |
PROSTATE MECHANICAL IMAGER |
ARTANN LABORATORIES, INC |
| K092138 |
07/15/2009 |
JTS EXTENDEABLE IMPLANT |
STANMORE IMPLANTS WORLDWIDE LTD. |
| K062125 |
07/25/2006 |
SUPERSTITCH 5F, 12F, AND EL |
SUTURA, INC. |
| K102118 |
07/28/2010 |
SNORE GUARD ADVANCE |
RANIR LLC |
| K002431 |
08/08/2000 |
ELRAN 01 SYSTEM |
ENVISION ADVANCED MEDICAL SYSTEM LTD |
| K082355 |
08/15/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
| K082667 |
09/12/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) |
VISIONSENSE, LTD. |
| K013253 |
09/28/2001 |
HISONIC-TRD TINNITUS RELIEF DEVICE |
HEARING INNOVATIONS, INC. |
| K112879 |
09/30/2011 |
REST ASSURED READY TO WEAR NITE PROTECTOR |
RANIR LLC |
| K103004 |
10/08/2010 |
SNORE GUARD |
RANIR LLC |
| K973873 |
10/10/1997 |
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 |
AMERICAN TELECARE, INC. |
| K123467 |
11/09/2012 |
VS3 |
VISIONSENSE, LTD. |
| K073279 |
11/21/2007 |
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
| K133152 |
11/22/2013 |
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT |
STANMORE IMPLANTS WORLDWIDE LTD. |
| K053482 |
12/14/2005 |
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW |
SUTURA, INC. |
| K963678 |
09/13/1996 |
CARETONE II |
AMERICAN TELECARE, INC. |
| K033830 |
12/10/2003 |
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 |
OPTICON MEDICAL, INC. |
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