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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 16 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions PRO6040
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14296
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9396
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7248C
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3429E
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8113
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7715A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7574
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7449
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13912
FDA UDI
Class IActive
Aligned Medical Solutions AMS16602
FDA UDI
Class IActive
Aligned Medical Solutions WAL1226
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1080
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4705B
FDA UDI
Class IActive
Aligned Medical Solutions PRO6038
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6513C
FDA UDI
Class IActive
Aligned Medical Solutions AMS5976
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6499
FDA UDI
Class IActive
Aligned Medical Solutions AMS12065C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16123A
FDA UDI
Class IActive
Aligned Medical Solutions AMS4246A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9967A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7067G
FDA UDI
Class IActive
Aligned Medical Solutions AMS15115
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14143
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12090C
FDA UDI
Class IIActive
Aligned Medical Solutions LK151WVB
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13350
FDA UDI
Class IActive
Aligned Medical Solutions AMS10410A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS2886A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13391B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12735A
FDA UDI
Class IIActive
Aligned Medical Solutions RMS1790
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16700
FDA UDI
Class IActive
Aligned Medical Solutions 114AMS03
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4913A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13147B
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3339
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3723
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4246
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11032A
FDA UDI
Class IActive
Aligned Medical Solutions VPP1024
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13941A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6283A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5750B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1027A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6397A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14223
FDA UDI
Class IActive
Aligned Medical Solutions AMS1432
FDA UDI
Class IActive
Aligned Medical Solutions AMS13957
FDA UDI
Class IActive

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