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Waters Instruments, Inc.

United StatesFDA applicant, unverified

Devices
12

What Waters Instruments, Inc. makes

Waters Instruments, Inc. manufactures medical devices for monitoring vital signs, renal preservation, and gastrointestinal management. Their product line includes pulse oximeters (e.g., OSC-80, OXICOM-2100, OXICOMPLUS), renal preservation systems (e.g., RM3 with control units), and catheters for thermal dilution cardiac output measurements (e.g., TX-2, Polyurethane Thermal Dilution Catheter). Additional offerings include ileal reservoir and ileostomy valves for ostomy care.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

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  • Osc-80 Oximeter Ref K862161

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • RM3 Renal Preservation System Ref K053169

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • RM3 Renal Preservation System--Control Unit Ref K971571

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oxicomplus Ref K911207

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waters Ileal Reservoir Catheter Ref K813494

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Oxicom-2100 Ref K921519

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Velcom-100 Ref K863210

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tx-2 Thermal Dilution Cardiac Output Ref K834408

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mvp - 6000 Ref K852909

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Polyurethane Thermal Dilution Cathet Ref K841876

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • RM3 Renal Preservation System Ref K042224

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waters Ileostomy Valve Ref K813585

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-12 of 12

Frequently asked questions

How many devices does Waters Instruments, Inc. have in the registry?

The registry currently lists 12 devices for Waters Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Waters Instruments, Inc.'s devices?

Among its 12 most recently registered devices, Waters Instruments, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Waters Instruments, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Waters Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Waters Instruments, Inc. in the registry?

The most recently registered devices listed for Waters Instruments, Inc. include OSC-80 OXIMETER, RM3 RENAL PRESERVATION SYSTEM, RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT and OXICOMPLUS.

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