FDA 510(k) Applications Submitted by FRED MA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K963204 |
08/15/1996 |
DMS-1000C DERMOABRADER |
AESTHETIC LASERS, INC. |
| K122663 |
08/31/2012 |
ORAMOIST |
QUANTUM, INC. |
| K162613 |
09/19/2016 |
Integrated Catch-up Freedom Syringe Driver Infusion System |
Repro-Med Systems, Inc., DBA RMS Medical Products |
| K133542 |
11/18/2013 |
PURACYN PLUS SKIN AND WOUND |
INNOVACYN, INC. |
| K090692 |
03/16/2009 |
ORTHOLOC 2.0/2.4 PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K081479 |
05/27/2008 |
ADVANCE A-CLASS TIBIAL INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K180295 |
02/01/2018 |
Hamilton-G5 |
Hamiton Medical AG |
| K000496 |
02/15/2000 |
EVERSHEARS BIPOLAR SCISSORS |
EVEREST MEDICAL CORP. |
| K020585 |
02/22/2002 |
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT |
GYRUS MEDICAL, INC. |
| K993412 |
10/12/1999 |
BITX PROBES |
EVEREST MEDICAL CORP. |
| K023492 |
10/18/2002 |
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS |
GYRUS MEDICAL, INC. |
| K023493 |
10/18/2002 |
PK ZIP WING CUTTING DISSECTOR |
GYRUS MEDICAL, INC. |
| K994336 |
12/23/1999 |
BITX PROBES |
EVEREST MEDICAL CORP. |
| K081851 |
06/30/2008 |
NEOSS ACCESS ABUTMENTS |
NEOSS, LTD. |
| K071838 |
07/05/2007 |
NEOSS VARIOUS TITANIUM ABUTMENTS |
NEOSS LTD |
|
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