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Shelhigh, Inc.

United StatesFDA applicant, unverified

Devices
8
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Shelhigh, Inc. makes

Shelhigh, Inc. manufactures surgical patches and tissue repair products designed for vascular, pericardial, and dural applications. These include no-react biopatches for vascular closure, pericardial repair, and pleural adhesion prevention, as well as dural shields and urological repair patches. Additional offerings include a biocuff for vascular support and pneumoplegets for lung tissue adhesion management.

The company’s products are classified under FDA Class II medical devices and are listed via 510(k) clearance in the United States. The portfolio is regulated under US FDA requirements, with devices authorised for commercial distribution through the 510(k) pathway.

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

Catalogue8

Newest first, rows 1-8 of 8

FDA recalls2

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

FDA recall records list 2 recalls initiated by Shelhigh, Inc., the earliest on 2003-12-19 and the most recent on 2006-01-18. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination. 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.

  • 2006

    • 18 Jan 2006 Z-0678-06 Unclassified (pre-2012) Terminated Unapproved Device-Distribution of an unapproved device into interstate commerce. Distribution: The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital…
      Full distribution text The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized salesman). The firm subsequently shipped a recalled unit, S/N PE20677 on 11/8/2005 to a European Distributor, Bioplan SRL, Parma, Italy. There are no Govt. accounts.

  • 2003

    • 19 Dec 2003 Z-0588-04 Unclassified (pre-2012) Terminated The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile. Distribution: The product is distributed natiowide to 19 different hospitals.

Frequently asked questions

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

The registry currently lists 8 devices for Shelhigh, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shelhigh, Inc.'s devices?

Among its 8 most recently registered devices, Shelhigh, Inc. has devices listed in FDA 510(k) (8 devices).

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

Among its 8 most recently registered devices, the classes recorded for Shelhigh, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Shelhigh, Inc.?

FDA recall records list 2 recalls initiated by Shelhigh, Inc., the most recent initiated on 18 Jan 2006. 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 Shelhigh, Inc. in the registry?

The most recently registered devices listed for Shelhigh, Inc. include SHELHIGH NO-REACT VASCUPATCH, SHELHIGH NO-REACT PERICARDIAL PATCHES, SHELHIGH NO-REACT BIOCUFF and SHELHIGH NO-REACT PNEUMOPLEDGETS.

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