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MicroSurgical Technology Inc.

United States US-MF-000020475 Last updated 25 Oct 2026

Devices
910
Registries
EUDAMEDGUDIDFDA
FDA recalls
22 ongoing

Catalogue910

Page 2 of 19

Showing 51-100 of 910

FDA recalls2

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2025

    • 20 Aug 2025 Z-0411-2026 Class II Ongoing An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritationvia FDA establishment MICROSURGICAL TECHNOLOGY, INC.

  • 2024

    • 17 Sep 2024 Z-0521-2025 Class II Ongoing Due to pin coming off of handles.via FDA establishment MICROSURGICAL TECHNOLOGY, INC.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Microsurgical Technology, Inc. Redmond, WA · US FEI 3019924

What MicroSurgical Technology Inc. makes

MicroSurgical Technology Inc. manufactures surgical instruments and devices for ophthalmic procedures, including the Malyugin Ring System for cataract surgery and the Trabectome and TrabEx+ for glaucoma management. These tools are designed for minimally invasive eye surgeries, such as trabeculectomy and phacoemulsification.

The company’s portfolio includes devices classified as Class IIa and Class IIb under EU regulations, with products listed in the eudamed database. The company is based in the United States.

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 MicroSurgical Technology Inc. manufacture?

MicroSurgical Technology Inc. specializes in surgical instruments and devices for ophthalmic procedures. Their portfolio includes tools like the Malyugin Ring System, which is used in cataract surgery, and the Trabectome and TrabEx+, designed for glaucoma management. These devices are intended for minimally invasive eye surgeries such as trabeculectomy and phacoemulsification, focusing on precision and reduced invasiveness.

Where is MicroSurgical Technology Inc. based?

MicroSurgical Technology Inc. is headquartered in the United States. The company’s location in the US influences its regulatory and market focus, particularly in alignment with US and EU standards for ophthalmic surgical devices.

Which regulatory registries list MicroSurgical Technology Inc.’s devices?

MicroSurgical Technology Inc.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion ensures transparency and traceability for devices classified under EU regulations, such as Class IIa and Class IIb.

How are MicroSurgical Technology Inc.’s devices classified under EU regulations?

MicroSurgical Technology Inc.’s devices fall under Class IIa and Class IIb classifications in the EU. Class IIa devices pose a low-to-moderate risk and require conformity assessment procedures like design examination and manufacturing quality assurance, while Class IIb devices carry a higher risk and require additional scrutiny, such as clinical evaluations or performance studies, to ensure safety and performance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States(from SRN)
Address
8415 154TH AVE NE, REDMOND, United States
Phone
425-284-9409
PRRC contact
Farha Shafi Ahmed
EUDAMED SRN
US-MF-000020475
DUNS number
097824130