FDA 510(k) Applications Submitted by Janell Colley
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120284 |
01/31/2012 |
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX |
COLOPLAST A/S |
| K971984 |
05/29/1997 |
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) |
MICROVENA CORP. |
| K972511 |
07/03/1997 |
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER |
MICROVENA CORP. |
| K181918 |
07/18/2018 |
CardioInsight Cardiac Mapping System |
Medtronic, Inc. |
| K093112 |
10/01/2009 |
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE |
COLOPLAST MANUFACTURING US, LLC |
| K113496 |
11/25/2011 |
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT |
COLOPLAST A/S |
| K121562 |
05/29/2012 |
ALTIS SINGLE INCISION CLING SYSTEM |
COLOPLAST A/S |
| K982077 |
06/12/1998 |
SELECTOR DIAGNOSTIC CATHETER |
BOSTON SCIENTIFIC SCIMED, INC. |
| K111881 |
07/01/2011 |
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT |
COLOPLAST A/S |
| K992276 |
07/07/1999 |
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM |
SULZER SPINE-TECH |
| K012305 |
07/23/2001 |
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM |
SULZER SPINE-TECH |
| K132632 |
08/22/2013 |
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES |
TORNIER, INC. |
| K993067 |
09/13/1999 |
SILHOUETTE SPINAL FIXATION SYSTEM |
SULZER SPINE-TECH |
| K023300 |
10/03/2002 |
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J |
GUIDANT CORP. |
| K133376 |
11/04/2013 |
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT |
TORNIER, INC. |
| K083499 |
11/25/2008 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
COLOPLAST A/S |
| K103568 |
12/06/2010 |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
COLOPLAST A/S |
| K083770 |
12/18/2008 |
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
COLOPLAST A/S |
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