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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 27 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS17151
FDA UDI
Class IActive
Aligned Medical Solutions AMS12176A
FDA UDI
Class IActive
Aligned Medical Solutions AMS6810
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11776B
FDA UDI
Class IActive
Aligned Medical Solutions AMS8420
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14629A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14927
FDA UDI
Class IIActive
Aligned Medical Solutions WAL1207A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9210
FDA UDI
Class IActive
Aligned Medical Solutions AMS7101B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4420A
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3466C
FDA UDI
Class IActive
Aligned Medical Solutions AMS4245
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12293
FDA UDI
Class IIActive
Aligned Medical Solutions CH1014
FDA UDI
Class IIActive
Aligned Medical Solutions AMS17008
FDA UDI
Class IActive
Aligned Medical Solutions AMS11905
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12757
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7248B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6446C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4692
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5395C
FDA UDI
Class IActive
Aligned Medical Solutions RAC320
FDA UDI
Class IIUnknown
Aligned Medical Solutions CPA33363
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14428
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12646
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11396B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3550B
FDA UDI
Class IActive
Aligned Medical Solutions AMS10820A
FDA UDI
Class IActive
Aligned Medical Solutions 26000004K
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11638B
FDA UDI
Class IActive
Aligned Medical Solutions AMS13723
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14059A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11764A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11242
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14408
FDA UDI
Class IIActive
Aligned Medical Solutions RMS1637J
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14472
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4222
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13551
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9083E
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9774
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5966D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14128
FDA UDI
Class IActive
Aligned Medical Solutions AMS9111
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2954
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3409C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6566E
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9013B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8130C
FDA UDI
Class IIActive

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