Atlas FDA

QSZ

19 FDA 510(k) clearances · Product code

118 daysmedian time to decision
279 days90th percentile
19clearances measured

FDA profile

Official device name
Absorbable Synthetic Wound Dressing
Device class
Unclassified
Medical specialty
Unknown
FDA definition
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Adverse events (MAUDE)
2025: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Redermo Wound Matrix (K260020)Beijing Kreate Medical Co., Ltd.2026-04-16
NovoSorb BTM (K251567)Polynovo Biomaterials Pty, Ltd.2025-06-20
NovoSorb® MTX (K242149)Polynovo Biomaterials Pty, Ltd.2025-03-05
SiOxD® Wound Matrix (K241660)Sioxmed, LLC2024-07-05
SiOxD Wound Matrix (K232847)Sioxmed, LLC2023-12-18
Restrata® MiniMatrix (K223725)Acera Surgical, Inc.2023-05-18
SiOxD Wound Matrix (K222189)Sioxmed, LLC2022-11-18
NovoSorb Matrix (K221686)Polynovo Biomaterials Pty, Ltd.2022-09-15
Restrata® (K193583)Acera Surgical, Inc.2020-09-25
Phoenix Wound Matrix (K173544)Nanofiber Solutions, Inc.2018-03-02
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) (K172140)Polynovo Biomaterials Pty, Ltd.2017-08-11
SupraSDRM Biodegradable Matrix Wound Dressing (K170213)Polymedics Innovations, GmbH2017-06-28
Restrata Wound Matrix (K170300)Acera Surgical, Inc.2017-04-26
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (K161067)Engineered Tissue Solutions, LLC2016-09-15
BTM Wound Dressing (K142879)Polynovo Biomaterials Pty, Ltd.2015-12-23
GORE BIO-A WOUND MATRIX (K132397)W. L. Gore & Associates, Inc.2014-05-07
SUPRATHEL WOUND AND BURN DRESSING (K090160)Polymedics Innovations, GmbH2009-05-20
HYALOMATRIX PA (K073251)Fidia Advanced Biopolymers Srl2007-12-14
TOPKIN WOUND DRESSING (K031684)Biomet Merck GmbH2003-10-30

Track QSZ automatically

Every clearance here is in the API, with alerts when new ones post.