Micro-tech USA
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Micro-tech USA is a medical device manufacturer, with 73 devices listed in FDA GUDID (FDA Class II and I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 73
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 73
- Device classes
- FDA Class II 43
- FDA Class I 30
- FDA recalls
- Identifiers
- DUNS 079873914
At a glance
Market reach
- United States
- FDA recalls
What Micro-tech USA makes
Micro-tech USA manufactures single-use accessories and components for endoscopic procedures, including insufflation tubing sets, valve kits for endoscope channels, cleaning utensils for surgical instruments, and bite blocks. Their portfolio also covers reusable and single-use items like reusable Bovie cords, irrigation tubing, and endoscopy preparation kits, as well as collection containers for surgical suction systems. These products are designed to support preparation, cleaning, and operation during endoscopic and surgical procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
Catalogue
Search and filter all 73 devicesShowing 1-50 of 73
Company details
- DUNS number
- 079873914
FDA recalls
FDA recall records list 1 recall initiated by Micro-tech Usa, initiated on 2020-10-05. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 5 Oct 2020 Z-0470-2021 Class II Terminated FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
Full distribution text
- 5 Oct 2020 Z-0470-2021 Class II Terminated FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
Frequently asked questions
How many devices does Micro-tech Usa have in the registry?
The registry currently lists 73 devices for Micro-tech Usa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro-tech Usa's devices?
Among its 50 most recently registered devices, Micro-tech Usa has devices listed in FDA GUDID (50 devices).
What risk classes do Micro-tech Usa's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Micro-tech Usa's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Micro-tech Usa?
FDA recall records list 1 recall initiated by Micro-tech Usa, the most recent initiated on 5 Oct 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Micro-tech Usa in the registry?
The most recently registered devices listed for Micro-tech Usa include Endoscopy Kit - Basic Aux HB DKT1HA0008A, 3-Piece Valve Kit BW01-FUJ3-F7, Active Cord Reusable Bovie AEC-03-08 and 5-Piece Valve Kit BW01-FUJ5-F56.