Skip to content

Hydro-Med Products, Inc.

United StatesFDA applicant, unverified

Devices
13
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Hydro-Med Products, Inc. makes

Hydro-Med Products, Inc. makes disposable medical drapes and covers for imaging and surgical equipment, including X-ray drapes, ultrasound probe drapes, sterile TV camera and cord covers, universal video/laser arm drapes, surgical microscope drapes, limb covers, and camera covers with tear tips. The company also produces sterile disposable spinal needles, infant scale disposable liners, and products such as The Pathfinder, EasyTop, and Therapak.

The manufacturer's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Hydro-Med Products, Inc. is based in the United States.

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

Catalogue13

Newest first, rows 1-13 of 13

Search and filter all 13 devices
Skip device list

  • The Pathfinder Ref K842304

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

  • X-Ray Drapes Ref K923099

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

  • Sterile Disposable Spinal Needles Ref K834407

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

  • Camera Cover With Tear Tip Ref K940152

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

  • Easytop Ref K853281

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

  • Infant Scale Disposable Liner Ref K790659

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

  • Thera-Pak Ref K780452

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

  • Ultrasound Probe Drape Ref K940151

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

  • Sterile Tv Camera & Cord Cover Ref K812405

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

  • Universal Video/Laser Arm Drape Ref K934630

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

  • Surgical Microscope Drape Ref K944198

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

  • Limb Cover Ref K780905

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

  • Tamper Hamper Ref K863872

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

Rows 1-13 of 13

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 Hydro-Med Products, Inc., initiated on 2000-09-28. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. 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.

  • 2000

    • 28 Sep 2000 Z-0384-05 Unclassified (pre-2012) Terminated Defective packaging, potential for breech in sterility. Distribution: The product was distributed nationwide to distributors and hospitals in the following states IA, WV, OR, PA, CA, and TN Submission number: K940151

Frequently asked questions

How many devices does Hydro-Med Products, Inc. have in the registry?

The registry currently lists 13 devices for Hydro-Med Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hydro-Med Products, Inc.'s devices?

Among its 13 most recently registered devices, Hydro-Med Products, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Hydro-Med Products, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Hydro-Med Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Hydro-Med Products, Inc.?

FDA recall records list 1 recall initiated by Hydro-Med Products, Inc., the most recent initiated on 28 Sep 2000. 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 Hydro-Med Products, Inc. in the registry?

The most recently registered devices listed for Hydro-Med Products, Inc. include THE PATHFINDER, X-RAY DRAPES, STERILE DISPOSABLE SPINAL NEEDLES and CAMERA COVER WITH TEAR TIP.

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