Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Advance Medical Designs, Inc.

United States·US-MF-000009790

Last updated September 17, 2026

About

Trust Advance Medical Designs for innovative surgical infection control. High-quality products and solutions designed for superior OR patient safety.

From the manufacturer's own website. Source

What Advance Medical Designs, Inc. makes

The company manufactures single-use sterile drapes and covers for medical instruments and equipment, including surgical drapes, handle covers, and CO₂ tank covers. It also produces extracorporeal circuit waste bags, in-line arterial blood sampling sets, surgical irrigators, needle guides, and general-purpose fluid transfer sets.

These products are classified as Class I or Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Advance Medical Designs, Inc. manufacture?

Advance Medical Designs, Inc. specializes in single-use, sterile medical devices primarily focused on infection control and surgical safety. Their products include instrument/equipment drapes, medical equipment handle covers, surgical drapes, extracorporeal circuit waste bags, in-line arterial blood sampling sets, surgical fluid/gas irrigators, needle guides, and general-purpose fluid transfer sets. These items are designed to minimize contamination risks during medical procedures.

Where is Advance Medical Designs, Inc. based, and what regulatory databases list its devices?

Advance Medical Designs, Inc. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps healthcare providers and regulators identify and verify the devices in circulation.

How are the devices manufactured by Advance Medical Designs, Inc. classified under FDA regulations?

The devices produced by Advance Medical Designs, Inc. fall under two primary classifications: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part or condition it addresses.

Why are the devices from Advance Medical Designs, Inc. listed as single-use?

The devices from Advance Medical Designs, Inc. are designed as single-use to ensure patient safety and infection control. Single-use items are intended for one-time use and disposal after a single procedure, reducing the risk of cross-contamination between patients. This approach aligns with best practices in healthcare to minimize the spread of infections and maintain sterile environments during medical treatments.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
1241 Atlanta Industrial Drive, Marietta, United States
Phone
1 (770) 422 3125
PRRC Contact
David Mackie
EUDAMED SRN
US-MF-000009790
FDA FEI Number
1037885
DUNS Number
—

Catalogue (871)

Page 18 of 18
DeviceModel / ReferenceRegistriesClassStatus
Flex-Guard Mesh Large Single Finger Trap A-30522-2
EUDAMEDFDA UDI
Class IActive
Low Dense Polyethylene Snap Kover 40" X 20" 01-4020
EUDAMEDFDA UDI
Class IActive
Surefire 28-TPU166
EUDAMEDFDA UDI
Class IActive
Low Dense Polyethylene Snap Kover 40" X 60" 01-4060
EUDAMEDFDA UDI
Class IActive
ASonic 50-GEL20
EUDAMED
Class IActive
Surefire 28-TPG114
EUDAMEDFDA UDI
Class IActive
Surefire 28-TPG116
EUDAMEDFDA UDI
Class IActive
Low Dense Polyethylene Snap Kover 36" X 28" 01-3628
EUDAMEDFDA UDI
Class IActive
Flex-Guard Mesh Extra LG Double Finger Trap A-30522-7
EUDAMEDFDA UDI
Class IActive
Sterile Ura Drain Bag KYRA8411
EUDAMED
Class IActive
Flex-Guard Mesh Arm Trap A-21200
EUDAMED
Class IActive
Transfer Device 10-108
EUDAMEDFDA UDI
Class IActive
Accu-Guide 28-GG308
EUDAMEDFDA UDI
Class IActive
Sterile Filter Drape 85234007452
EUDAMED
Class IActive
LPDE Camera Cover PDE120
EUDAMED
Class IActive
Low Dense Polyethylene Snap Kover 44" X 25" 01-4425
EUDAMEDFDA UDI
Class IActive
Camera Arm Drape BTR08CC602
EUDAMED
Class IActive
Low Dense Polyethylene Snap Kover 28" X 20" 01-2820
EUDAMEDFDA UDI
Class IActive
Accu-Guide 28-GG500
EUDAMEDFDA UDI
Class IActive
Bottle Decanter 10-104
EUDAMEDFDA UDI
Class IActive
Low Dense Polyethylene Snap Kover 40" X 30" 01-4030
EUDAMEDFDA UDI
Class IActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Advance Medical Designs, Inc. has seven FDA recall records, with the earliest initiated on June 18, 2004, and the most recent on July 7, 2023. The records reflect recalls with statuses marked as open, classified, and terminated. The reasons cited include mislabeling of ultrasound gel regarding inappropriate use and a potential structural failure where the product may detach when excessive force is applied to the coupler.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jul 7, 2023Z-2532-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023Z-2537-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023Z-2536-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023Z-2533-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023Z-2535-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023Z-2534-2023—open, classified

Ultrasound gel mislabeled with inappropriate use.

Jun 18, 2004Z-1036-04—terminated

The product may come apart when excessive force is applied to the coupler.