FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K170300 |
Acera Surgical, Inc. |
Restrata Wound Matrix |
04/26/2017 |
K193583 |
Acera Surgical, Inc. |
Restrata« |
09/25/2020 |
K031684 |
BIOMET MERCK GMBH |
TOPKIN WOUND DRESSING |
10/30/2003 |
K161067 |
ENGINEERED TISSUE SOLUTIONS, LLC |
Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö |
09/15/2016 |
K173544 |
Nanofiber Solutions, Inc. |
Phoenix Wound Matrix |
03/02/2018 |
K170213 |
PolyMedics Innovations GmbH |
SupraSDRM Biodegradable Matrix Wound Dressing |
06/28/2017 |
K090160 |
POLYMEDICS INNOVATIONS GMBH |
SUPRATHEL WOUND AND BURN DRESSING |
05/20/2009 |
K142879 |
POLYNOVO BIOMATERIALS PTY LTD |
BTM Wound Dressing |
12/23/2015 |
K172140 |
PolyNovo Biomaterials Pty Ltd |
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) |
08/11/2017 |
K221686 |
PolyNovo Biomaterials Pty Ltd |
NovoSorb Matrix |
09/15/2022 |
K132397 |
W. L. GORE & ASSOCIATES, INC. |
GORE BIO-A WOUND MATRIX |
05/07/2014 |