Skip to content

Sharn, Inc.

United StatesFDA applicant, unverified

Devices
4
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sharn, Inc. makes

Sharn, Inc. manufactures diagnostic and procedural devices, including an esophageal stethoscope for auscultation, a topical applicator for localized treatment delivery, an EVAC-TUBE for drainage applications, and the Vila-Cooke™ anesthesia pillow for patient positioning during procedures.

The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the company operates from the United States.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Esophageal Stethoscope Ref K860558

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

  • Topical Applicator Ref K070596

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

  • Evac-Tube Ref K894032

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

  • Vila-Cooke(Tm) Anesthesia Pillow Ref K932305

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

FDA recalls3

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

FDA recall records list 3 recalls initiated by Sharn, Inc., initiated on 2009-03-05. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. 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.

  • 2009

    • 5 Mar 2009 Z-0265-2010 Unclassified (pre-2012) Terminated Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. Distribution: Nationwide Distribution Submission number: K070596
    • 5 Mar 2009 Z-0266-2010 Unclassified (pre-2012) Terminated Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. Distribution: Nationwide Distribution Submission number: K070596
    • 5 Mar 2009 Z-0267-2010 Unclassified (pre-2012) Terminated Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device. Distribution: Nationwide Distribution Submission number: K070596

Frequently asked questions

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

The registry currently lists 4 devices for Sharn, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sharn, Inc.'s devices?

Among its 4 most recently registered devices, Sharn, Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Sharn, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sharn, Inc.?

FDA recall records list 3 recalls initiated by Sharn, Inc., the most recent initiated on 5 Mar 2009. 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 Sharn, Inc. in the registry?

The most recently registered devices listed for Sharn, Inc. include ESOPHAGEAL STETHOSCOPE, TOPICAL APPLICATOR, EVAC-TUBE and VILA-COOKE(TM) ANESTHESIA PILLOW.

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