FDA 510(k) Applications Submitted by Denise Thompson
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040538 |
03/02/2004 |
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 |
AMERICAN MEDICAL SYSTEMS, INC. |
| K130559 |
03/04/2013 |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
Greatbatch Medical |
| K090713 |
03/18/2009 |
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP |
AMERICAN MEDICAL SYSTEMS, INC. |
| K051530 |
06/09/2005 |
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. |
AMERICAN MEDICAL SYSTEMS, INC. |
| K081710 |
06/17/2008 |
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS |
| K012208 |
07/16/2001 |
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 |
BECKMAN COULTER, INC. |
| K122832 |
09/17/2012 |
MOBICATH TRANSSEPTAL NEEDLE |
Greatbatch Medical |
| K023093 |
09/18/2002 |
ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
| K023369 |
10/08/2002 |
ACCESS TOTAL T4 ASSAY |
BECKMAN COULTER, INC. |
| K023480 |
10/17/2002 |
ACCESS TOTAL BHCG |
BECKMAN COULTER, INC. |
| K003259 |
10/18/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 |
BECKMAN COULTER, INC. |
| K193502 |
12/18/2019 |
TGS Universal Headrest with Mounting Arm |
Stryker ENT |
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