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Ohio Medical Instrument Co., Inc.

United StatesFDA applicant, unverified

Devices
19
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Ohio Medical Instrument Co., Inc. makes

Ohio Medical Instrument Co., Inc. manufactures neurosurgical devices including skull clamps, head clamps, retractors, and surgical tables. Their product range consists of disposable and reusable skull pins, radiolucent skull clamps, and specialized neurosurgical systems for cranial surgery.

The company's devices are listed in the FDA 510(k) registry and include Class I and Class II medical devices. Ohio Medical Instrument Co., Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

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FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Ohio Medical Instrument Co., Inc., initiated on 2003-02-26. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 26 Feb 2003 Z-0781-03 Unclassified (pre-2012) Terminated The component was manufactured with an insufficient weld that could break during use. Distribution: The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong…
      Full distribution text The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany.
      Submission number: K830332

Frequently asked questions

How many devices does Ohio Medical Instrument Co., Inc. have in the registry?

The registry currently lists 19 devices for Ohio Medical Instrument Co., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ohio Medical Instrument Co., Inc.'s devices?

Among its 19 most recently registered devices, Ohio Medical Instrument Co., Inc. has devices listed in FDA 510(k) (19 devices).

What risk classes do Ohio Medical Instrument Co., Inc.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Ohio Medical Instrument Co., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ohio Medical Instrument Co., Inc.?

FDA recall records list 1 recall initiated by Ohio Medical Instrument Co., Inc., the most recent initiated on 26 Feb 2003. 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 Ohio Medical Instrument Co., Inc. in the registry?

The most recently registered devices listed for Ohio Medical Instrument Co., Inc. include CUDDLE UP PILLOW, MAYFIELD ADULT DISPOSABLE SKULL PIN, MAYFIELD RADIOLUCENT SKULL CLAMP and THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F.

Generated automatically from registry data and not verified by a human reviewer.