FDA 510(k) Applications Submitted by JOHN GREEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K032742 |
09/04/2003 |
SILVER FOAM WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
| K024298 |
12/24/2002 |
ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
| K040171 |
01/26/2004 |
MICRODERM, MODEL/VERSION 3.5 |
VISIOMED AG |
| K050225 |
02/01/2005 |
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K100362 |
02/12/2010 |
CAMBRIDGE HEART OEM |
CAMBRIDGE HEART, INC. |
| K010756 |
03/13/2001 |
CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K010758 |
03/13/2001 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS |
CAMBRIDGE HEART, INC. |
| K001034 |
03/31/2000 |
MODEL APS ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
| K011324 |
05/01/2001 |
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K121326 |
05/02/2012 |
LANTOS 3D EAR SCANNER |
LANTOS TECHNOLOGIES |
| K022149 |
07/02/2002 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
| K022152 |
07/02/2002 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
| K081961 |
07/09/2008 |
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
| K012206 |
07/13/2001 |
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
| K002230 |
07/24/2000 |
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
CAMBRIDGE HEART, INC. |
| K042231 |
08/17/2004 |
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
| K023089 |
09/17/2002 |
GELSPHERES EMBOLIC AGENT |
BIOCURE, INC. |
| K013201 |
09/25/2001 |
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR |
CARDIOFOCUS, INC. |
| K072822 |
10/02/2007 |
FUNHALER, MODEL V-201E |
INFAMED LTD. |
| K083091 |
10/17/2008 |
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
| K013564 |
10/26/2001 |
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
| K013565 |
10/26/2001 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
| K003492 |
11/13/2000 |
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
CAMBRIDGE HEART, INC. |
| K073199 |
11/13/2007 |
3M ESPE LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
| K033761 |
12/02/2003 |
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
| K073663 |
12/26/2007 |
GELSPRAY WOUND DRESSING |
BIOCURE, INC. |
| K094018 |
12/29/2009 |
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
| K981697 |
05/11/1998 |
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K963136 |
08/13/1996 |
PACER MODEL 100 INFUSION CONTROLLER |
HEALTH WATCH, INC. |
| K983102 |
09/03/1998 |
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 |
CAMBRIDGE HEART, INC. |
| K042546 |
09/20/2004 |
FUNHALER, MODEL FH 101 |
INFAMED LTD. |
| K011339 |
05/02/2001 |
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 |
SPACELABS BURDICK, INC. |
| K041316 |
05/17/2004 |
ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
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