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Porex Surgical, Inc.

United StatesFDA applicant, unverified

Devices
19
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Porex Surgical, Inc. makes

Porex Surgical, Inc. manufactures MEDPOR surgical implant materials, craniofacial implants with embedded titanium mesh, orbital volume replacement implants, barrier surgical implant biomaterials, fixation systems, attractor implants, contain can implants, and attractor magnetic coupling systems, as well as Porex nostril retainers and electrosurgery needles.

The company's portfolio includes Class I, Class II, and U devices, which are listed in the FDA 510(k) registry. Porex Surgical, Inc. is based in the US.

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

Catalogue19

Newest first, rows 1-19 of 19

Search and filter all 19 devices
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Rows 1-19 of 19

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Porex Surgical, Inc., the earliest on 2005-03-07 and the most recent on 2008-03-28. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use 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.

  • 2008

    • 28 Mar 2008 Z-2302-2008 Unclassified (pre-2012) Terminated The Ocular Conformers were distributed with an expired expiration date. Distribution: PA, Canada and Germany Submission number: K972034

  • 2006

    • 11 Jul 2006 Z-1515-06 Unclassified (pre-2012) Terminated Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material Distribution: Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC,…
      Full distribution text Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany

  • 2005

    • 7 Mar 2005 Z-0712-05 Unclassified (pre-2012) Terminated The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres Distribution: AZ, IL, NJ and Korea Submission number: K863943

Frequently asked questions

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

The registry currently lists 19 devices for Porex Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Porex Surgical, Inc.'s devices?

Among its 19 most recently registered devices, Porex Surgical, Inc. has devices listed in FDA 510(k) (19 devices).

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

Among its 19 most recently registered devices, the classes recorded for Porex Surgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Porex Surgical, Inc.?

FDA recall records list 3 recalls initiated by Porex Surgical, Inc., the most recent initiated on 28 Mar 2008. 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 Porex Surgical, Inc. in the registry?

The most recently registered devices listed for Porex Surgical, Inc. include MEDPOR SURGICAL GRANULE IMPLANTS, POREX NOSTRIL RETAINERS, MEDPOR QUAD MOTILITY IMPLANT and MEDPOR SURGICAL IMPLANT MATERIAL.

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