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Customed, Inc.

United StatesFDA applicant, unverified FDA FEI 2648727

Customed, Inc. is a medical device manufacturer, with 136 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.

Devices
136
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 100
  • FDA 510(k) 36

A device listed in two registries counts in both.

Device classes
  • FDA Class II 105
  • FDA Class I 30
Identifiers
  • FDA FEI 2648727
  • DUNS 627572217

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Customed, Inc. makes

Customed, Inc. makes single-use medical devices such as basic endotracheal tubes, cell-block cytology aspiration needles, and airway suction catheters. They also produce sterilization packaging, surgical/medical face masks, and various types of biopsy needles. Additionally, they manufacture hevea-latex surgical gloves. These products are used in medical settings for various procedures and patient care.

The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA's 510k and UDI registries.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue136

Newest first, rows 1-50 of 136

Search and filter all 136 devices
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  • Sterile Suture Removal Kit Ref K925015

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

  • Customed 712057831816

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

  • Customed 712057102985

    Listed Registry: GUDID Class:I

  • Customed 712057462213

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

  • Customed 712057839016

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

  • Customed 712057143009 Open recall

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

  • Customed 152570148306

    Listed Registry: GUDID Class:II

  • Customed 712057837016

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

  • Customed 712057102988

    Listed Registry: GUDID Class:I

  • Customed 712057712783

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

  • Customed 712057342983

    Listed Registry: GUDID Class:II

  • Customed 712057839825

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

  • Customed 712057342982

    Listed Registry: GUDID Class:II

  • Customed 712057470015

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

  • Customed 712057462218

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

  • Customed 712057830810

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

  • Customed 712057470030

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

  • Customed 712057831812

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

  • Customed 712057470040

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

  • Customed 152570148312

    Listed Registry: GUDID Class:II

  • Customed 712057143002 Open recall

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

  • Customed 712057103144

    Listed Registry: GUDID Class:I

  • Customed 712057143016 Open recall

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

  • Customed 712057462214

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

  • Customed Or Turnover Drape With Transfer Sheet

    Listed Registry: GUDID Class:I

  • Customed 712057143010 Open recall

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

  • Customed 712057342981

    Listed Registry: GUDID Class:II

  • Customed 712057470020

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

  • Customed 712057712784

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

  • Customed 712057831115

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

  • Customed 712057143007 Open recall

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

  • Customed 712057471070

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

  • Customed 712057102987

    Listed Registry: GUDID Class:I

  • Customed 712057143106

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

  • Customed 712057837020

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

  • Customed 712057700051

    Listed Registry: GUDID Class:I

  • Customed 712057102984

    Listed Registry: GUDID Class:I

  • Customed 712057103092

    Listed Registry: GUDID Class:I

  • Customed 712057143001 Open recall

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

  • Customed 712057143014 Open recall

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

  • Customed 712057839116

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

  • Customed 712057143005 Open recall

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

  • Customed 712057052781

    Listed Registry: GUDID Class:II

  • Customed 712057052780

    Listed Registry: GUDID Class:II

  • Customed 712057693050

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

  • Customed 712057693051

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

  • Customed 712057832116

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

  • Customed 712057832020

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

  • Customed 712057143006 Open recall

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

  • Customed 712057470054

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

Rows 1-50 of 136

Showing 1-50 of 136

Company details

FDA FEI number
2648727
DUNS number
627572217
Address
CALLE IGUALDAD No. 7, Fajardo, PR, 00738
Phone
787-622-5151

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • CustoMED Ltd IL

Frequently asked questions

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

The registry currently lists 136 devices for Customed, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Customed, Inc.'s devices?

Among its 50 most recently registered devices, Customed, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 50 most recently registered devices, the classes recorded for Customed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Customed, Inc. in the registry?

The most recently registered devices listed for Customed, Inc. include STERILE SUTURE REMOVAL KIT, CUSTOMED 712057831816, CUSTOMED 712057102985 and CUSTOMED 712057462213.

Which FDA establishments are linked to Customed, Inc.?

1 FDA establishment is linked to Customed, Inc. in the registry; they are listed on the company page.

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