FDA 510(k) Applications Submitted by Deana Boushell
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070167 |
01/18/2007 |
ENDOBUTTON DIRECT |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K080358 |
02/11/2008 |
PLLA, HA SCREW |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K160645 |
03/07/2016 |
PreSep Oligon Oximetry Catheter |
EDWARDS LIFESCIENCES, LLC |
| K070908 |
04/02/2007 |
SMITH & NEPHEW KINSA RC SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K991413 |
04/23/1999 |
CODMAN ETHISORB DURA PATCH |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K061154 |
04/26/2006 |
KINSA SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
| K062607 |
09/05/2006 |
POLYGRAFT BGS |
SMITH & NEPHEW, INC. |
| K983141 |
09/08/1998 |
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K152633 |
09/15/2015 |
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe |
EDWARDS LIFESCIENCES, LLC |
| K052652 |
09/26/2005 |
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE |
SMITH & NEPHEW, INC. |
| K072785 |
10/01/2007 |
TWINFIX FT PK |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K102982 |
10/07/2010 |
ENDOBUTTON DIRECT |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K123170 |
10/09/2012 |
VARI-PASS VARIABLE LENGTH ACCESS SHEATH |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| K053344 |
12/02/2005 |
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
| K073509 |
12/13/2007 |
TWINFIX PK FP SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
| K063726 |
12/15/2006 |
PLC SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K964795 |
11/29/1996 |
CEMENTED CALCAR REPLACEMENT FEMORAL STEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K964923 |
12/09/1996 |
CODMAN LUMBAR DRAINAGE CATHETER KIT |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
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