FDA 510(k) Applications Submitted by JOHN J SMITH, M.D. J.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K111274 |
05/05/2011 |
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 |
JETPREP, LTD. |
| K111314 |
05/10/2011 |
MORPHEUS OX |
WIDEMED LTD |
| K092174 |
07/21/2009 |
ENABLER-P CATHETER SYSTEM, MODEL 3000 |
ENDOCROSS, LTD. |
| K083833 |
12/23/2008 |
ENABLER-P CATHETER, 1000 PART NUMBER:1160 |
ENDOCROSS, LTD. |
| K122740 |
09/06/2012 |
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN |
JETPREP, LTD. |
| K120025 |
01/03/2012 |
SURGIMESH XB - SKIRTED |
ASPIDE MEDICAL |
| K090050 |
01/07/2009 |
STEREOS WORKSTATION |
BIOSPACE MED |
| K130057 |
01/09/2013 |
ESPIN |
NLT SPINE LTD |
| DEN130016 |
01/30/2013 |
XSTAT |
REVMEDX, INC. |
| K130395 |
02/15/2013 |
STEREOS WORKSTATION |
EOS IMAGING INC. |
| K120553 |
02/23/2012 |
ESPIN |
NLT SPINE LTD |
| K080529 |
02/26/2008 |
STEREOS WORKSTATION |
BIOSPACE MED |
| K120721 |
03/08/2012 |
EOS |
EOS IMAGING |
| K130743 |
03/19/2013 |
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL |
ORTHO KINEMATICS, INC. |
| K130790 |
03/22/2013 |
LYRIC2 |
PHONAK LLC |
| K110812 |
03/23/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
| K100889 |
03/31/2010 |
ENDOSKELETON TC |
TITAN SPINE, LLC |
| K141137 |
05/01/2014 |
STEREOS WORKSTATION |
EOS IMAGING |
| K101398 |
05/18/2010 |
STEREOS WORKSTATION |
BIOSPACE MED |
| K071546 |
06/06/2007 |
EOS |
BIOSPACE MED |
| K112109 |
07/22/2011 |
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE |
ORTHO KINEMATICS, INC. |
| K082339 |
08/14/2008 |
ENABLER-P SUPPORT CATHETER |
ENDOCROSS, LTD. |
| K112359 |
08/16/2011 |
PROW FUSION |
NLT SPINE LTD |
| K122768 |
09/10/2012 |
GENESIS |
DORNIER MEDTECH AMERICA, INC. |
| K133061 |
09/27/2013 |
ESPIN SYSTEM |
NLT SPINE LTD |
| K113063 |
10/14/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
| K123354 |
10/31/2012 |
REVITIVE IX |
Actegy Ltd |
| K113344 |
11/14/2011 |
STEREOS WORKSTATION |
EOS IMAGING |
| K123740 |
12/05/2012 |
EOS |
EOS IMAGING |
| K133875 |
12/20/2013 |
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA |
ORTHO KINEMATICS, INC. |
| K133906 |
12/23/2013 |
C-JAWS CERVICAL COMPRESSIVE STAPLE |
MEDICREA INTERNATIONAL |
| K100836 |
03/24/2010 |
CLEARPOINT SYSTEM |
SURGIVISION, INC. |
| K123390 |
11/02/2012 |
PEDIGUARD NERVE DETECTOR SYSTEM |
SPINEGUARD, S.A. |
| K120300 |
01/31/2012 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
| K130338 |
02/11/2013 |
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS |
IMPEDIMED LIMITED |
| K140772 |
03/27/2014 |
AEROSURE MEDIC |
Actegy Ltd |
| K131375 |
05/13/2013 |
AUTOLAP SYSTEM |
MST - MEDICAL SURGERY TECHNOLOGIES LTD. |
| K134052 |
12/31/2013 |
RADIANCE 330 PROTON THERAPY SYSTEM |
ProTom International, Inc. |
| K130951 |
04/05/2013 |
SIM |
SIMAVITA PTY LIMITED |
| K962075 |
05/28/1996 |
HSW GMBH ARTHROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
| K960255 |
01/17/1996 |
CERAMIC BLADE ELECTRODE |
UTAH MEDICAL PRODUCTS, INC. |
| K960496 |
02/01/1996 |
LIBERTY LITE PFS SYSTEM |
UTAH MEDICAL PRODUCTS, INC. |
| K990396 |
02/09/1999 |
T-ANASTAFLO |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
| K991170 |
04/07/1999 |
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
| K001565 |
05/19/2000 |
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB |
EDWARDS LIFESCIENCES, LLC. |
| K972273 |
06/18/1997 |
TBD |
MEGADYNE MEDICAL PRODUCTS, INC. |
| K982826 |
08/11/1998 |
MEGA 2000 |
MEGADYNE MEDICAL PRODUCTS, INC. |
| K973346 |
09/05/1997 |
UNCOATED ELECTROSURGICAL ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
| K983791 |
10/27/1998 |
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
| K964526 |
11/12/1996 |
LIBERTY RECTAL PELVIC FLOOR EXERCISER |
UTAH MEDICAL PRODUCTS, INC. |
| K955663 |
12/13/1995 |
ABC IN-LINE BLOOD SAMPLING KIT |
UTAH MEDICAL PRODUCTS, INC. |
| K965245 |
12/31/1996 |
TBD |
UTAH MEDICAL PRODUCTS, INC. |
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