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Sign in to claim this brandAESDEX, LLC
US
Last updated May 30, 2026
What AESDEX, LLC makes
AESDEX, LLC manufactures single-use surgical staple loading units designed for non-cutting applications, including curved and straight reloads for endoscopic linear cutting staplers. Their portfolio also includes reusable open-surgery blood vessel sizers for measuring vascular grafts and anastomosis systems for vascular-grafting procedures, such as distal and proximal attachment devices.
The company’s devices are regulated under FDA’s classification system, with products falling into Class I and Class II categories. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
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 AESDEX, LLC manufacture?
AESDEX, LLC specializes in surgical devices primarily used in vascular and endoscopic procedures. Their portfolio includes single-use surgical staple loading units (such as curved and straight reloads for linear cutting staplers), vascular-grafting anastomosis systems (for connecting blood vessels), and reusable open-surgery blood vessel sizers (to measure graft diameters). These devices support minimally invasive and open-surgery applications in cardiovascular and vascular care.
Where is AESDEX, LLC based, and how does that affect its regulatory oversight?
AESDEX, LLC is based in the United States, which means its devices are subject to FDA regulation under U.S. medical device laws. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they must comply with FDA requirements for traceability, labeling, and post-market surveillance. The UDI system helps ensure transparency and regulatory tracking for these devices.
Which regulatory registries or databases list AESDEX, LLC’s devices?
AESDEX, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database, a centralized system that assigns a standardized identifier to medical products. This listing helps healthcare providers, regulators, and supply chains track devices like the MicroCutter reloads and Cardica anastomosis systems for compliance and recall purposes. The UDI system is mandatory for Class II devices and voluntary for Class I, ensuring traceability across the device lifecycle.
How are AESDEX, LLC’s devices classified under FDA regulations?
AESDEX, LLC’s devices fall into FDA Class I and Class II categories. Class I typically includes low-risk devices like reusable blood vessel sizers, which generally require only general controls (e.g., good manufacturing practices). Class II devices, such as single-use staple reloads and anastomosis systems, require additional performance standards or post-market surveillance due to moderate risks (e.g., ensuring proper sealing in vascular procedures). The classification determines the regulatory scrutiny and labeling requirements for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 081132841
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MicroCutter 30 Curved Tip Blue Reload | FG-025321 | FDA UDI | Class II | Active |
| MicroCutter 30 Curved Tip White Reload | FG-025311 | FDA UDI | Class II | Active |
| MicroCutter 30 White Reload | FG-025310 | FDA UDI | Class II | Active |
| Cardica Vein/Aorta Gauge | FG-000003 | FDA UDI | Class I | Active |
| MicroCutter 30 Blue Reload | FG-025320 | FDA UDI | Class II | Active |
| Dextera MicroCutter 5/80 Stapler | FG-025302 | FDA UDI | Class II | Active |
| Cardica C-Port xA Plus Anastomosis System | FG-000100 | FDA UDI | Class II | Active |
| Cardica C-Port Flex-A Plus Distal Anastomosis System | FG-000150 | FDA UDI | Class II | Active |
| Cardica PAS-Port Proximal Anastomosis System | FG-000001 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
AESDEX, LLC has two recall records, both initiated on 2018-04-02, with both currently marked as terminated. The reasons provided relate to the potential for damage to the device handle mechanism during pressurization, which may result in a loud noise and the dispersion of plastic fragments and components.
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 |
|---|---|---|---|---|
| Apr 2, 2018 | Z-2434-2018 | — | terminated | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |
| Apr 2, 2018 | Z-2433-2018 | — | terminated | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |