FDA 510(k) Applications Submitted by AUDREY A WITKO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020390 |
02/06/2002 |
MODIFICATION TO FETAL ASSIST |
HUNTLEIGH DIAGNOSTICS LTD. |
| K961166 |
03/25/1996 |
FLOWTRON EXCEL PUMP |
HNE HEALTHCARE, INC. |
| K012008 |
06/27/2001 |
STS RANGE , MODELS STS20,STS30,STS40 |
HUNTLEIGH HEALTHCARE, INC. |
| K992733 |
08/13/1999 |
AKRON ATP9 TRACTION MACHINE |
HUNTLEIGH TECHNOLOGY, INC. |
| K022786 |
08/22/2002 |
DVT60 |
HUNTLEIGH HEALTHCARE, INC. |
| K963711 |
09/16/1996 |
BABY DOPPLEX (3000) |
HUNTLEIGH HEALTHCARE, INC. |
| K123166 |
10/09/2012 |
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P |
HOWMEDICA OSTEONICS CORP |
| K123486 |
11/13/2012 |
TRIATHLON TRITANIUM TIBIAL BASEPLATE |
Stryker |
| K964699 |
11/25/1996 |
RHEO DOPPLEX II (RD 2) |
HUNTLEIGH TECHNOLOGY, INC. |
| K984307 |
12/02/1998 |
MODIFICATION OF: RHEO DOPPLEX II |
HUNTLEIGH HEALTHCARE, INC. |
| K965153 |
12/23/1996 |
HUNTLEIGH FP5000 SYSTEM MODEL FP5000 |
HUNTLEIGH HEALTHCARE, INC. |
| K001882 |
06/21/2000 |
BABY DOPPLEX 4002-TWINS, MODEL BD4002 |
HUNTLEIGH HEALTHCARE, INC. |
| K002186 |
07/20/2000 |
VASCULAR ASSIST |
HUNTLEIGH HEALTHCARE, INC. |
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