MED WAY INC.

FDA Device Registration & Listing · Buford, GA, US · Registration 3012084379

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
3012084379
FEI Number
3012084379
Entity Name
MED WAY INC.
City/State/Country
Buford, GA, US
Establishment Address
1650 Horizon PKWY NE, Suite 450, Buford, GA 30518, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Med Way Inc. (Owner Number: 10050401)
Owner / Operator Contact Address
1650 Horizon PKWY NE, Suite 450, Buford, GA 30518, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Support Surfaces Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Foam Dressing Kit Silicone Dressing; Super Absorbency Dressing; Nonwoven Wound Dressing; Foam Dressing Scar Gel Sheet Hydrogel Dressing Film Dressing Silicone Scar Sheet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FNM Mattress, Air Flotation, Alternating Pressure General Hospital Class 2 880.5550 2024-09-18
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2020-05-04
PFP Silicone Hydrogel For Scar Management General, Plastic Surgery Class 1 878.4025 2024-09-17
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2024-09-17
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2024-09-17
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2024-09-17

Official Correspondent

Ahmed Alawad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Med Way 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
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019 COVIDIEN LLC 1
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012084379. Last updated year: 2026. Please use registration number 3012084379 when referencing this establishment in official correspondence.
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