FDA 510(k) Applications Submitted by GAIL YAEKER-DAUNIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180496 |
02/26/2018 |
TruClear Elite Hysteroscope |
Covidien |
| K030666 |
03/03/2003 |
MULTICARE PLATINUM SYSTEM AND ACCESSORIES |
LORAD, A HOLOGIC CO. |
| K100692 |
03/10/2010 |
DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
| K040884 |
04/05/2004 |
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
| K140960 |
04/15/2014 |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
HOLOGIC, INC. |
| K071542 |
06/05/2007 |
DIGITAL STEREOLOC II |
LORAD, A HOLOGIC CO. |
| K151581 |
06/11/2015 |
Leva Spacer System |
SPINE WAVE, INC. |
| K062107 |
07/24/2006 |
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 |
HOLOGIC, INC. |
| K152620 |
09/14/2015 |
Spine Wave Gen II Expandable Interbody System |
SPINE WAVE, INC. |
| K122836 |
09/17/2012 |
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
LORAD, A HOLOGIC CO. |
| K153222 |
11/06/2015 |
Leva Spacer System |
SPINE WAVE, INC. |
| K123530 |
11/16/2012 |
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) |
HOLOGIC, INC. |
| K103385 |
11/18/2010 |
SECURVIEW DX DIAGNOSTIC WORKSTATION |
HOLOGIC, INC. |
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