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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 31 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS7297
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12062B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9525
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15669A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8027
FDA UDI
Class IActive
Aligned Medical Solutions AMS14296B
FDA UDI
Class IIActive
Aligned Medical Solutions CCE4535S
FDA UDI
Class IIActive
Aligned Medical Solutions CMP1016D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16498
FDA UDI
Class IActive
Aligned Medical Solutions AMS9359
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14696A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10256B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8809
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7837
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6784
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8929D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6568C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10415B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4796A
FDA UDI
Class IActive
Aligned Medical Solutions INT0400
FDA UDI
Class IActive
Aligned Medical Solutions AMS5263
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15854
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9773
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14075B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11475A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14215C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12417A
FDA UDI
Class IActive
Aligned Medical Solutions AMS3155F
FDA UDI
Class IActive
Aligned Medical Solutions AMS12605
FDA UDI
Class IIActive
Aligned Medical Solutions 0098114
FDA UDI
Class IIActive
Aligned Medical Solutions 007912-9
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1504
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4887A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11079
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14499
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12879
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10878B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4840
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2905
FDA UDI
Class IActive
Aligned Medical Solutions AMS13667
FDA UDI
Class IIActive
Aligned Medical Solutions AMS17225
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14906
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3653D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13651
FDA UDI
Class IActive
Aligned Medical Solutions AMS7134A
FDA UDI
Class IActive
Aligned Medical Solutions AMS6570A
FDA UDI
Class IIActive
Aligned Medical Solutions CH1002
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1082
FDA UDI
Class IActive
Aligned Medical Solutions AMS7687
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6414A
FDA UDI
Class IIActive

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