FDA 510(k) Applications Submitted by ANN WATERHOUSE, RAC
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K020043 |
01/07/2002 |
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B |
ARTHREX, INC. |
K050259 |
02/03/2005 |
ARTHREX BIO-PIN |
ARTHREX, INC. |
K050358 |
02/14/2005 |
ARTHERX CORKSCREW FT II SUTURE ANCHOR |
ARTHREX, INC. |
K110455 |
02/15/2011 |
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS |
KIMBERLY-CLARK CORP. |
K060478 |
02/23/2006 |
ARTHREX BIO-COMPRESSION SCREW |
ARTHREX, INC. |
K050749 |
03/23/2005 |
ARTHREX TAK FAMILY |
ARTHREX, INC. |
K011007 |
04/04/2001 |
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 |
ARTHREX, INC. |
K021434 |
05/06/2002 |
ARTHREX FIBERWIRE IN USP SIZES |
ARTHREX, INC. |
K041189 |
05/06/2004 |
ARTHREX TRIMIT FAMILY |
ARTHREX, INC. |
K011495 |
05/15/2001 |
ARTHREX BIO-POST AND WASHER |
ARTHREX, INC. |
K041356 |
05/20/2004 |
ARTHREX TENODESIS SCREW FAMILY |
ARTHREX, INC. |
K031666 |
05/29/2003 |
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS |
ARTHREX, INC. |
K041553 |
06/09/2004 |
ARTHREX SUTURE GRAFTING KIT |
ARTHREX, INC. |
K041589 |
06/11/2004 |
ARTHREX FIBERWIRE WITH SILK |
ARTHREX, INC. |
K061665 |
06/14/2006 |
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT |
ARTHREX, INC. |
K071622 |
06/14/2007 |
ARTHREX FIBERWIRE |
ARTHREX, INC. |
K031945 |
06/24/2003 |
ARTHREX TRIMIT SCREW, MODEL AR-4161B |
ARTHREX, INC. |
K061863 |
06/30/2006 |
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY |
ARTHREX, INC. |
K032098 |
07/08/2003 |
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B |
ARTHREX, INC. |
K022234 |
07/11/2002 |
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B |
ARTHREX, INC. |
K032245 |
07/22/2003 |
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 |
ARTHREX, INC. |
K122473 |
08/14/2012 |
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 |
HILL-ROM |
K062466 |
08/24/2006 |
ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
K072378 |
08/24/2007 |
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 |
ARTHREX, INC. |
K012923 |
08/31/2001 |
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 |
ARTHREX, INC. |
K052387 |
08/31/2005 |
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX |
ARTHREX, INC. |
K062747 |
09/14/2006 |
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM |
ARTHREX, INC. |
K023119 |
09/19/2002 |
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B |
ARTHREX, INC. |
K052607 |
09/22/2005 |
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS |
ARTHREX, INC. |
K052736 |
09/30/2005 |
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT |
ARTHREX, INC. |
K052901 |
10/14/2005 |
ARTHREX TENSIONLOK |
ARTHREX, INC. |
K103150 |
10/26/2010 |
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK |
KIMBERLY-CLARK |
K113340 |
11/14/2011 |
KIMBERLY-CLARK CHILD'S FACEMASK |
KIMBERLY-CLARK |
K063479 |
11/17/2006 |
ARTHREX PUSHLOCK |
ARTHREX, INC. |
K143414 |
11/28/2014 |
Hill-Rom Wireless Connectivity Module |
HILL-ROM |
K053338 |
12/01/2005 |
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS |
ARTHREX, INC. |
K023986 |
12/02/2002 |
ARTHREX OPES ELECTRODES AND ACCESSORIES |
ARTHREX, INC. |
K063719 |
12/15/2006 |
ARTHREX CROSSPIN, MODEL AR-1964P |
ARTHREX, INC. |
K014155 |
12/19/2001 |
OPENING/CLOSING WEDGE OSTETOMY PLATES |
ARTHREX, INC. |
K053543 |
12/20/2005 |
ARTHREX ARTHOERESIS IMPLANT |
ARTHREX, INC. |
K050634 |
03/09/2005 |
MODIFICATION TO: ARTHREX V-TAK |
ARTHREX, INC. |
K071176 |
04/27/2007 |
MODIFICATION TO: ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
K111402 |
05/19/2011 |
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL |
KIMBERLY-CLARK |
|
|