FDA 510(k) Applications Submitted by MICHELLE HUETTNER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130115 |
01/16/2013 |
DISCOVERY MR750W 3.0T |
GE MEDICAL SYSTEMS, LLC |
| K210566 |
02/26/2021 |
LEGION Porous CR Narrow Femoral Components |
Smith & Nephew, Inc. |
| K170872 |
03/23/2017 |
Aisys CS2 |
Datex-Ohmeda, Inc. |
| K121762 |
06/15/2012 |
CARDIAC VX |
GE MEDICAL SYSTEMS, LLC |
| K191734 |
06/28/2019 |
MatriStem UBM Pericardial Patch |
Acell, Inc. |
| K122174 |
07/23/2012 |
PEDIATRIC POSITIONER PAD SET |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
| K132376 |
07/30/2013 |
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T |
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
| K192725 |
09/27/2019 |
Cytal Wound Matrix 3-Layer |
ACell, Inc. |
| K123522 |
11/15/2012 |
OPTIMA MR450W |
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
| K143530 |
12/12/2014 |
Aespire View |
Datex-Ohmeda, Inc. |
|
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