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Aligned 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
—
LinkedIn
—
Facebook
—
Phone
+1(888)637-7056
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
106580145

Catalogue (5375)

Page 24 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS5867C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10064
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7874C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4672
FDA UDI
Class IActive
Aligned Medical Solutions AMS7524A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13321A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS2127C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10260
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7335A
FDA UDI
Class IActive
Aligned Medical Solutions AMS6380
FDA UDI
Class IActive
Aligned Medical Solutions AMS9009
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1881
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8245
FDA UDI
Class IIActive
Aligned Medical Solutions DDS1161
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7543
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13849B
FDA UDI
Class IActive
Aligned Medical Solutions AMS9906A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9241
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14857
FDA UDI
Class IIActive
Aligned Medical Solutions 00930712
FDA UDI
Class IIActive
Aligned Medical Solutions 3755S
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16702
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16091
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2621A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3324C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4144A
FDA UDI
Class IActive
Aligned Medical Solutions AMS3151E
FDA UDI
Class IActive
Aligned Medical Solutions AMS7463B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10885
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5060A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14805A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13852
FDA UDI
Class IActive
Aligned Medical Solutions AMS12880
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16542
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13957A
FDA UDI
Class IActive
Aligned Medical Solutions AMS15408
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15246
FDA UDI
Class IIActive
Aligned Medical Solutions 0021363
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13956A
FDA UDI
Class IActive
Aligned Medical Solutions AMS15194
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6274B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5903C
FDA UDI
Class IActive
Aligned Medical Solutions AMS7789
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1829A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16431
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3240
FDA UDI
Class IActive
Aligned Medical Solutions AMS5184B
FDA UDI
Class IIActive
Aligned Medical Solutions DDS1126
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3199C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15585
FDA UDI
Class IIActive

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