FDA 510(k) Applications Submitted by JULIE STEPHENS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110062 |
01/10/2011 |
MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG |
MEDIPURPOSE PTE. LTD. |
| K130132 |
01/18/2013 |
BABYLANCE HEEL INCISION DEVICE |
MEDIPURPOSE PTE. LTD. |
| K060170 |
01/23/2006 |
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS |
ERBE USA, INC. |
| K060484 |
02/24/2006 |
ERBE VIO ESU, MODEL VIO 300 D |
ERBE USA, INC. |
| K080779 |
03/19/2008 |
IRRISEPT WOUND CLEANSING SYSTEM |
IRRIMAX CORPORATION |
| K130948 |
04/05/2013 |
C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
SOUTHERN SPINE, LLC |
| K101145 |
04/23/2010 |
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 |
MEDIPURPOSE PTE. LTD. |
| K101417 |
05/20/2010 |
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 |
MEDIPURPOSE PTE. LTD. |
| K051509 |
06/07/2005 |
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES |
ERBE USA, INC. |
| K032239 |
07/21/2003 |
THERA-CREAM, MODEL TCT004 |
PRIZM MEDICAL, INC. |
| K052055 |
07/29/2005 |
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 |
SMISSON-CARTLEDGE BIOMEDICAL LLC |
| K082584 |
09/08/2008 |
GIVEN ELECTROSURGICAL NEEDLE |
TRIPPS COURT ENTERPRISES, INC |
| K133046 |
09/27/2013 |
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS |
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA |
| K123093 |
10/02/2012 |
STABILINK MIS SPINAL FIXATION SYSTEM |
SOUTHERN SPINE, LLC |
| K033421 |
10/27/2003 |
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS |
ERBE USA, INC. |
| K083452 |
11/21/2008 |
ERBE MODEL VIO 300 D WITH ACCESSORIES |
ERBE USA, INC. |
| K024047 |
12/09/2002 |
ERBE VIO APC WITH ACCESSORIES |
ERBE USA, INC. |
| K123908 |
12/19/2012 |
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES |
MATRIX SURGICAL USA |
| K063764 |
12/20/2006 |
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM |
SOUTHERN SPINE, LLC |
| K960400 |
01/29/1996 |
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) |
SNOWDEN-PENCER |
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