ADVAMEDICA INC.

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3017391151

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
3017391151
FEI Number
3017391151
Entity Name
ADVAMEDICA INC.
City/State/Country
Cambridge, MA, US
Establishment Address
Harvard Square, 1 Mifflin place, Suite 400, Cambridge, MA 02138, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
ADVAMEDICA INC. (Owner Number: 10077783)
Owner / Operator Contact Address
Harvard Square, 1 Mifflin place, Suite 400, Cambridge, MA 02138, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202830
PMA Number
N/A

All Registered Proprietary Names

Ax-Surgi Maxiocel Chitosan Wound Dressing Axiostat Gauze AXIOSTAT PATCH

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POD Temporary, Internal Use Hemostatic General, Plastic Surgery Class 2 878.4454 2023-05-09
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-01-04
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2023-05-08
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2021-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ADVAMEDICA INC.
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
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K220566 Koag, LLC Vascette HP (hemostatic pad) 2022-07-29
K080818 Hem Con Medical Technologies, Inc. HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING 2008-05-15
K893123 Les Laboratorires Brothier, S.A. ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES 1990-02-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017391151. Last updated year: 2026. Please use registration number 3017391151 when referencing this establishment in official correspondence.
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