FDA 510(k) Applications Submitted by BRYAN COWELL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140042 |
01/08/2014 |
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME |
LEMAITRE VASCULAR, INC. |
| K080711 |
03/13/2008 |
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION |
HOLOGIC, INC. |
| K111201 |
04/29/2011 |
C7 XR IMAGING SYSTEM |
LIGHTLAB IMAGING,INC. |
| K181366 |
05/23/2018 |
REDAPT Porous Acetabular Shell |
Smith & Nephew, Inc. |
| K181533 |
06/11/2018 |
EVOS Wrist Fracture Plating System |
Smith & Nephew, Inc. |
| K192155 |
08/09/2019 |
Smith & Nephew DYONICS 25 Fluid Management System |
Smith & Nephew, Inc. |
| K072847 |
10/04/2007 |
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
| K113584 |
12/05/2011 |
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER |
ST. JUDE MEDICAL |
| K123531 |
11/16/2012 |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
LEMAITRE VASCULAR, INC. |
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