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Sign in to claim this brandAdvance 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
- Website
- www.advancemedicaldesigns.com
- [email protected]
- Phone
- 1 (770) 422 3125
- PRRC Contact
- David Mackie
- EUDAMED SRN
- US-MF-000009790
- FDA FEI Number
- 1037885
- DUNS Number
- —
Catalogue (871)
Page 9 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultrasound Probe Cover Biopsy Needle Guide | 28-EG110 | FDA UDI | Class II | Active |
| Unbranded | 20-P3D448 | FDA UDI | Class II | Active |
| Unbranded | 07-KC04 | FDA UDI | Class I | Active |
| Unbranded | 63-PM12M | FDA UDI | Class II | Active |
| Unbranded | LK901NS | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | 28-EG131 | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide | 28-EG100 | FDA UDI | Class II | Active |
| Unbranded | 09-MK945 | FDA UDI | Class II | Active |
| Unbranded | 5001 | FDA UDI | Class II | Active |
| Micro-Kover for Leica | 09-MK955 | FDA UDI | Class II | Active |
| Unbranded | 07-PK806 | FDA UDI | Class II | Active |
| Unbranded | 72-CFS02 | FDA UDI | Class II | Active |
| Unbranded | 01-3628N | FDA UDI | Class II | Active |
| Disposable Equipment Cover | 4436-01 | FDA UDI | Class II | Active |
| Unbranded | 63-PM06M | FDA UDI | Class II | Active |
| Unbranded | 09-MK943 | FDA UDI | Class II | Active |
| Unbranded | 72-CFS01 | FDA UDI | Class II | Active |
| Micro Kover | 09-MK983 | FDA UDI | Class II | Active |
| Unbranded | ADD-061 | FDA UDI | Class II | Active |
| Unbranded | 07-CA114 | FDA UDI | Class II | Active |
| Unbranded | 09-MK650 | FDA UDI | Class II | Active |
| Micro Kover | 09-MK919 | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | 28-EG151 | FDA UDI | Class II | Active |
| Unbranded | 25-FF348 | FDA UDI | Class II | Active |
| Mircoscope Cover | 09-MK655 | FDA UDI | Class II | Active |
| Camera Drape | 04-CC226 | FDA UDI | Class II | Active |
| Easy Catcher | O-EC52-JP | FDA UDI | Class II | Active |
| Unbranded | 05-CD2720 | FDA UDI | Class II | Active |
| Sterile Equipment Cover | 07-PK823 | FDA UDI | Class II | Active |
| Unbranded | 5001NS | FDA UDI | Class II | Active |
| Unbranded | 02-3620TL | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | 28-EG175 | FDA UDI | Class II | Active |
| Disposable Equipment Cover | LKAV2NS | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide | 28-EG160 | FDA UDI | Class II | Active |
| Unbranded | FHK-01 | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biopsy Needle Guide | 28-GG523 | FDA UDI | Class II | Active |
| Soft Flex Probe Cover | 20-PC496 | FDA UDI | Class II | Active |
| Unbranded | 02-3030TL | FDA UDI | Class II | Active |
| Ultrasound Probe Cover Biospy Needle Guide | 28-EG108 | FDA UDI | Class II | Active |
| Unbranded | SYN-0033 | FDA UDI | Class II | Active |
| Fluid Warmer Drape | 05-FW3036 | FDA UDI | Class II | Active |
| Unbranded | 07-CA105 | FDA UDI | Class II | Active |
| Sterile Equipment Cover | 07-PK821 | FDA UDI | Class II | Active |
| Unbranded | 08-MK101 | FDA UDI | Class II | Active |
| Unbranded | 09-MK906 | FDA UDI | Class II | Active |
| Unbranded | 07-KC06 | FDA UDI | Class I | Active |
| Unbranded | PK805NS-UB | FDA UDI | Class II | Active |
| Unbranded | CMS04NS | FDA UDI | Class II | Active |
| Handle Cover | 07-HK120 | FDA UDI | Class II | Active |
| Unbranded | 77900 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 7, 2023 | Z-2532-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Z-2537-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Z-2536-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Z-2533-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Z-2535-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Z-2534-2023 | — | open, classified | Ultrasound gel mislabeled with inappropriate use. |
| Jun 18, 2004 | Z-1036-04 | — | terminated | The product may come apart when excessive force is applied to the coupler. |