FDA 510(k) Applications Submitted by DIANE MANDELL HORWITZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090081 |
01/12/2009 |
TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS |
TALLADIUM ESPANA S.L. |
| K080538 |
02/26/2008 |
IDEAL LIFE POD (MODEL ILP 0001) |
IDEAL LIFE INC. |
| K121370 |
05/07/2012 |
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE |
VECTEC |
| K112634 |
09/09/2011 |
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP |
INOTEC AMD LTD. |
| K103536 |
12/01/2010 |
IBED WIRELESS WITH IBED AWARENESS |
STRYKER CORPORATION |
| K133872 |
12/20/2013 |
ARIA WIFI SMART SCALE |
FITBIT, INC. |
| K121993 |
07/06/2012 |
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
HEIDELBERG ENGINEERING GMBH |
| K133396 |
11/06/2013 |
VDRIVE WITH V-SONO |
STEREOTAXIS, INC. |
| K140804 |
03/31/2014 |
VDRIVE WITH V-LOOP/ VDRIVE DUO |
STEREOTAXIS, INC. |
| K122595 |
08/24/2012 |
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM |
DERMAL LIFE LLC |
| K091815 |
06/18/2009 |
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 |
Biotest Medical Corp. |
| K113807 |
12/23/2011 |
DEXERYL CREAM |
PIERRE FABRE MEDICAL DEVICES |
| K073699 |
12/31/2007 |
MCT-DIABETES |
MYCARE TEAM, INC. |
| K101223 |
05/03/2010 |
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA |
HEIDELBERG ENGINEERING |
| K071976 |
07/17/2007 |
VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES |
VECTEC |
| K112470 |
08/26/2011 |
2GC HIP/KNEE MODULAR SPACER |
MANDELL HORWITZ CONSULTANTS LLC |
| K103707 |
12/20/2010 |
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE |
VECTEC |
|
|
