FDA 510(k) Applications Submitted by Tim Thomas
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070123 |
01/16/2007 |
TCA 5R / 5S |
DORNIER MEDTECH AMERICA, INC. |
| K020339 |
02/01/2002 |
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM |
DORNIER MEDTECH AMERICA, INC. |
| K070536 |
02/26/2007 |
MEDILAS D FAMILY LASERS |
DORNIER MEDTECH AMERICA, INC. |
| K090557 |
03/02/2009 |
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM |
GIVEN IMAGING LTD. |
| K101200 |
04/29/2010 |
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE |
GIVEN IMAGING LTD. |
| K101250 |
05/04/2010 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES |
GIVEN IMAGING LTD. |
| K091405 |
05/12/2009 |
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT |
GIVEN IMAGING LTD. |
| K141357 |
05/23/2014 |
BARRX FLEX RFA ENERGY GENERATOR |
COVIDIEN IIC |
| K021724 |
05/24/2002 |
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS |
DORNIER MEDTECH AMERICA, INC. |
| K061455 |
05/25/2006 |
DORNIER MEDILAS H 20 LASER |
DORNIER MEDTECH AMERICA, INC. |
| K221608 |
06/03/2022 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether |
AnX Robotica Corp |
| K231960 |
07/03/2023 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
AnX Robotica Corporation |
| K022544 |
08/01/2002 |
DORNIER MEDILAS H LASER FIBER CABLES |
DORNIER MEDTECH AMERICA, INC. |
| K102543 |
09/03/2010 |
BRAVO PH MONITORING SYSTEM AND ACCESSORIES |
GIVEN IMAGING LTD. |
| K103025 |
10/12/2010 |
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES |
GIVEN IMAGING LTD. |
| K103088 |
10/19/2010 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT |
GIVEN IMAGING LTD. |
| DEN120023 |
11/29/2012 |
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
| K123864 |
12/17/2012 |
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
| K160360 |
02/09/2016 |
Barrx FLEX RFA Energy Generator |
Covidien llc |
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