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Sign in to claim this brandAligned Medical Solutions
US
Last updated May 24, 2026
What Aligned Medical Solutions makes
Aligned Medical Solutions manufactures single-use surgical procedure kits for general surgery, orthopaedics, ophthalmology, obstetrics/gynaecology, and ENT, as well as medicated general surgical kits. Their portfolio also includes angiography kits and non-medicated epidural anaesthesia sets, designed for procedural use in clinical settings.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable US regulatory requirements for medical devices.
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 Aligned Medical Solutions primarily manufacture?
Aligned Medical Solutions specializes in single-use surgical procedure kits across multiple specialties, including general surgery, orthopaedics, ophthalmology, obstetrics/gynaecology, and ENT. Their portfolio also includes medicated general surgical kits, angiography kits, and non-medicated epidural anaesthesia sets. These devices are designed for procedural use in clinical environments, ensuring compatibility with various surgical needs.
Where is Aligned Medical Solutions based, and what regulatory framework does it follow?
Aligned Medical Solutions is based in the United States. As a US-based manufacturer, its devices must comply with applicable US regulatory requirements for medical devices, including those set by the FDA. The company’s products are developed and marketed within this regulatory environment.
Which regulatory registries list Aligned Medical Solutions’ devices?
Aligned Medical Solutions’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US market, allowing healthcare providers and regulators to access critical information about the devices.
How are Aligned Medical Solutions’ devices classified under FDA regulations?
Aligned Medical Solutions’ devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part involved.
What distinguishes Aligned Medical Solutions’ medicated surgical kits from their non-medicated counterparts?
Aligned Medical Solutions offers both medicated and non-medicated surgical kits, with the key difference being the inclusion of pharmaceutical agents in the medicated versions. Medicated kits are designed to deliver specific therapeutic substances during surgery, such as antimicrobials or other agents to support healing or reduce infection risk, whereas non-medicated kits provide sterile tools and materials without additional pharmaceutical components.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- alignedmedicalsolutions.com
- —
- —
- [email protected]
- Phone
- +1(888)637-7056
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 106580145
Catalogue (5375)
Page 104 of 108| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aligned Medical Solutions | PSS2875 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS8443 | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS7346 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS16955 | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS6499A | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS3798A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS4698B | FDA UDI | Class II | Active |
| Aligned Medical Solutions | 114AMS02 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS4021C | FDA UDI | Class I | Active |
| Aligned Medical Solutions | 00788611 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS7880B | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS15671A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS4803 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS6565B | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS14367A | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS14529A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS15656 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS4873B | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS14294C | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS12474E | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS5905C | FDA UDI | Class II | Active |
| Aligned Medical Solutions | PSS3540D | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS7973 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS14691 | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS16207 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS16018 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS13507 | FDA UDI | Class I | Active |
| Aligned Medical Solutions | 0078361 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | 0068803 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | PRO6010 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS1717C | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS1151 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS8671 | FDA UDI | Class I | Active |
| Aligned Medical Solutions | 0010718 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | LK162RKB | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS2408B | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS12357A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS6113C | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS16100 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS9014A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS15140B | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS9812 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS8775B | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS9935B | FDA UDI | Class I | Active |
| Aligned Medical Solutions | AMS13698A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS12021A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS10320A | FDA UDI | Class II | Active |
| Aligned Medical Solutions | B1094JBCD | FDA UDI | Class II | Active |
| Aligned Medical Solutions | AMS6680 | FDA UDI | Class II | Active |
| Aligned Medical Solutions | TVS2601 | FDA UDI | Class II | Unknown |
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