Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 96 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS15122
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4065A
FDA UDI
Class IActive
Aligned Medical Solutions AMS12820
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11480A
FDA UDI
Class IActive
Aligned Medical Solutions AMS6113A
FDA UDI
Class IActive
Aligned Medical Solutions AMS4331A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14498A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11070A
FDA UDI
N/AActive
Aligned Medical Solutions AMS2120E
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9186D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13959C
FDA UDI
Class IActive
Aligned Medical Solutions AMS3163B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12886A
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2692
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9359A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5374
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4726
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3548
FDA UDI
Class IActive
Aligned Medical Solutions R401TJPPAA
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14937
FDA UDI
Class IIActive
Aligned Medical Solutions R402C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13747B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8160
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12885
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14890
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16807
FDA UDI
Class IActive
Aligned Medical Solutions AMS16709
FDA UDI
Class IActive
Aligned Medical Solutions AMS12953A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13770B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5207
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14573
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10586B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16068
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14529
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14367
FDA UDI
Class IActive
Aligned Medical Solutions AMS16353A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14814A
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2640
FDA UDI
Class IIActive
Aligned Medical Solutions WAL1243A
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3391A
FDA UDI
Class IIActive
Aligned Medical Solutions PRO6009
FDA UDI
Class IIActive
Aligned Medical Solutions AU0325S
FDA UDI
Class IActive
Aligned Medical Solutions PHC1607
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12616
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4329B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15502
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5487A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16167A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6728A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13387A
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.