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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 106 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS8111
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16282
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15543
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14703
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3692A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10376
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10560
FDA UDI
Class IActive
Aligned Medical Solutions AMS12273
FDA UDI
Class IActive
Aligned Medical Solutions AMS7791
FDA UDI
Class IIActive
Aligned Medical Solutions AMS2703I
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14261
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13613
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8103A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10930
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14315A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6603A
FDA UDI
Class IActive
Aligned Medical Solutions AMS8258
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5340B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10280A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9850
FDA UDI
Class IActive
Aligned Medical Solutions AMS5685
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3231C
FDA UDI
Class IActive
Aligned Medical Solutions AMS8227
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7336
FDA UDI
Class IActive
Aligned Medical Solutions AQMS10331A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9908A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12214
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11080
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12109
FDA UDI
Class IActive
Aligned Medical Solutions AMS4035B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12578B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3152F
FDA UDI
Class IActive
Aligned Medical Solutions AMS15103
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11023
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1217A
FDA UDI
Class IIActive
Aligned Medical Solutions 007884-21
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5699B
FDA UDI
Class IIActive
Aligned Medical Solutions 0088784
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7163
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13596
FDA UDI
Class IActive
Aligned Medical Solutions PSS2365L
FDA UDI
Class IActive
Aligned Medical Solutions AMS8816A
FDA UDI
Class IIActive
Aligned Medical Solutions 0088683
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14477
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12478A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15547
FDA UDI
Class IActive
Aligned Medical Solutions AMS6570D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5396B
FDA UDI
Class IActive
Aligned Medical Solutions AMS9114
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13584A
FDA UDI
Class IActive

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