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Heritage Medical Products

United Statesfrom the FDA registration address FDA FEI 3003881889

Devices
2
Registrations
FDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Heritage Medical Products makes

Heritage Medical Products manufactures negative pressure wound therapy devices, including the WOUND-EVAC RS and WOUND-EVAC systems. These products are designed for managing acute and chronic wounds by applying controlled suction to promote healing.

The company’s portfolio is classified under FDA Class I medical devices and is supported by 510(k) clearances. The devices are listed in the FDA’s 510(k) registry, adhering to U.S. regulatory requirements. The manufacturer is based in the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

  • Wound-Evac Rs Ref K881012

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

  • Wound-Evac Ref K813341

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

Company details

FDA FEI number
3003881889
Address
10380 CR 6310, West Plains, MO, 65775

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Heritage Medical Products, initiated on 2016-09-02. 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.

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.

  • 2016

    • 2 Sep 2016 Z-0353-2020 Class II Terminated Potential for bed to drop suddenly at the head while a patient is laying on it. Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT,…
      Full distribution text Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.

Frequently asked questions

How many devices does Heritage Medical Products have in the registry?

The registry currently lists 2 devices for Heritage Medical Products. Devices recorded under merged duplicate company entries are counted once.

Which registries list Heritage Medical Products's devices?

Among its 2 most recently registered devices, Heritage Medical Products has devices listed in FDA 510(k) (2 devices).

What risk classes do Heritage Medical Products's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Heritage Medical Products's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Heritage Medical Products?

FDA recall records list 1 recall initiated by Heritage Medical Products, the most recent initiated on 2 Sep 2016. 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 Heritage Medical Products in the registry?

The most recently registered devices listed for Heritage Medical Products include WOUND-EVAC RS and WOUND-EVAC.

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