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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 18 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS14275
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3549A
FDA UDI
Class IActive
Aligned Medical Solutions 0021974
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12478B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4733
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14522A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14172A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13273
FDA UDI
Class IActive
Aligned Medical Solutions AMS15829
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13074
FDA UDI
Class IActive
Aligned Medical Solutions AMS16553
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10686C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16830
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6277A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13851A
FDA UDI
Class IActive
Aligned Medical Solutions 0090645
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6572A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4952A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9490
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7762
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14824A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14267B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6935
FDA UDI
Class IIActive
Aligned Medical Solutions PSS1838A
FDA UDI
Class IIActive
Aligned Medical Solutions 0070013
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8668A
FDA UDI
Class IIActive
Aligned Medical Solutions PSS1527F
FDA UDI
Class IIActive
Aligned Medical Solutions 0067240
FDA UDI
Class IIActive
Aligned Medical Solutions RMS1726A
FDA UDI
Class IIActive
Aligned Medical Solutions PRO6031
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8623
FDA UDI
Class IActive
Aligned Medical Solutions PSS3256C
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2051B
FDA UDI
Class IIActive
Aligned Medical Solutions DDS1156
FDA UDI
Class IActive
Aligned Medical Solutions CH1005
FDA UDI
Class IIActive
Aligned Medical Solutions LK160TLCD
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4883
FDA UDI
Class IActive
Aligned Medical Solutions AMS6271A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3156F
FDA UDI
Class IActive
Aligned Medical Solutions AMS12312
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6602B
FDA UDI
Class IActive
Aligned Medical Solutions AMS5083A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11773C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11765B
FDA UDI
Class IActive
Aligned Medical Solutions AMS8213A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9541
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6598B
FDA UDI
Class IActive
Aligned Medical Solutions PSS3479A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7127
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2691B
FDA UDI
Class IActive

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