FDA 510(k) Applications Submitted by STUART R GOLDMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120344 |
02/03/2012 |
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE |
RADIADYNE, LLC (SPECIFICATION DEVELOPER) |
| K130534 |
03/01/2013 |
DIPLOMAT |
DIPLOMAT DENTAL S.R.O. |
| K120792 |
03/15/2012 |
TIXOS IMPLANT SYSTEM |
LEADER ITALIA S.R.L. |
| K081237 |
05/01/2008 |
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT |
CRAFTMASTER CONTOUR EQUIPMENT, INC. |
| K141154 |
05/05/2014 |
OARTRAC SYSTEM |
RADIADYNE |
| K111291 |
05/06/2011 |
AIDITE ZIRCONIA DENTAL CERAMICS |
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD |
| K131336 |
05/09/2013 |
TX WHEELCHAIR CHASSIS |
JCM SEATING SOLUTIONS LTD |
| K091878 |
06/23/2009 |
OSSEOLINK DENTAL IMPLANT SYSTEM |
GLOBAL IMPLANT SOLUTIONS, LLC |
| K081850 |
06/30/2008 |
BISQUE ZIRCONIA BLANKS, TYPE BYZ |
ZIRCAR ZIRCONIA, INC. |
| K092534 |
08/19/2009 |
ALATUS VAGINAL BALLOON PACKING SYSTEM |
RADIADYNE |
| K082652 |
09/12/2008 |
BITTAR ZIRCONIA BLOCKS |
BITTAR ZIRCONIA BLOCK, LLC |
| K103076 |
10/18/2010 |
DYNAFLEX |
DYNAFLEX |
| K083231 |
11/03/2008 |
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT |
PANTHERA PRODUCTION AB |
| K093560 |
11/18/2009 |
UPCERA ZIRCONIA BLANKS |
SHENYANG UPCERA CO., LTD. |
| K093595 |
11/19/2009 |
CERAROOT IMPLANT SYSTEM |
ORAL ICEBERG S.L. |
| K133806 |
12/16/2013 |
M1 CAPNOGRAPHY MASK |
MONITOR MASK, INC. |
| K171860 |
06/22/2017 |
Sureclear aligners |
Emergo Global Consulting, LLC |
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