BIOWOUND SOLUTIONS

FDA Device Registration & Listing · Las Vegas, NV, US · Registration 3034456223

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034456223
FEI Number
3034456223
Entity Name
BIOWOUND SOLUTIONS
City/State/Country
Las Vegas, NV, US
Establishment Address
6823 W Post Rd Ste 102, Las Vegas, NV 89118, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
BioWound Solutions (Owner Number: 10093220)
Owner / Operator Contact Address
6823 W Post Road, Suite 102, Las Vegas, NV 89118, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K140456
PMA Number
N/A

All Registered Proprietary Names

Actigraft Plus System bio-ConneKt Wound Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-06-02
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-09-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2025-09-24
PMQ Peripheral Blood Processing Device For Wound Management Hematology Class 2 864.9245 2026-04-21
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2025-04-17

Official Correspondent

John Rogers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioWound Solutions
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034456223. Last updated year: 2026. Please use registration number 3034456223 when referencing this establishment in official correspondence.
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