FDA 510(k) Applications Submitted by David Thomas
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190175 |
02/01/2019 |
S-MAK XL |
Merit Medical Systems Inc. |
| K040913 |
04/08/2004 |
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) |
BAUSCH & LOMB |
| K251265 |
04/24/2025 |
Resilience Fully Covered Esophageal Stent System |
Merit Medical Systems, Inc. |
| K991444 |
04/26/1999 |
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY). |
COMPUTER MOTION, INC. |
| K211405 |
05/06/2021 |
Prelude Guide Sheath |
Merit Medical Systems, Inc. |
| K181200 |
05/07/2018 |
AEROmini Tracheobronchial Stent System |
Merit Medical Systems, Inc |
| K161392 |
05/19/2016 |
Elation Pulmonary Balloon Dilation |
MERIT MEDICAL SYSTEMS, INC. |
| K212152 |
07/09/2021 |
Prelude IDeal 9F Hydrophilic Sheath Introducer |
Merit Medical Systems |
| K151925 |
07/13/2015 |
Elation Wireguided Balloon Dilation Catheter |
MERIT MEDICAL SYSTEMS, INC. |
| K122089 |
07/16/2012 |
OSTIAL PRO STENT POSITIONING SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
| K082944 |
10/02/2008 |
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM |
BAUSCH & LOMB, INC. |
| K213434 |
10/22/2021 |
Elation Pulmonary Balloon Dilation Catheter |
Merit Medical Systems, Inc. |
| K003431 |
11/03/2000 |
ZEUS ROBOTIC SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
| K003661 |
11/28/2000 |
SOCRATES ROBOTIC TELEMONITORING SYSTEM |
COMPUTER MOTION, INC. |
| K173750 |
12/08/2017 |
Prelude IDeal Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
| K990691 |
03/03/1999 |
HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K991635 |
05/12/1999 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K991734 |
05/21/1999 |
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K003217 |
10/13/2000 |
HERMES PORT EXPANDER |
COMPUTER MOTION, INC. |
| K003222 |
10/16/2000 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K013551 |
10/24/2001 |
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
| K013804 |
11/15/2001 |
SOCRATES ROBOTIC TELEMONITORING SYSTEM |
COMPUTER MOTION, INC. |
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