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Burton Medical Products Corp.

United StatesFDA applicant, unverified

Devices
15
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Burton Medical Products Corp. makes

Burton Medical Products Corp. manufactures a range of medical examination and surgical lighting systems, including portable exam lights (e.g., OPAL, PEARL), ceiling-mounted surgical lights (e.g., GENIE, SATURN), and specialized task lights (e.g., HALUX). Their portfolio also includes fluorescent magnifiers (e.g., WAVE) and minor/major surgical lights (e.g., OUTPATIENT III, AIM 200). These devices are designed for use in clinical, outpatient, and surgical settings.

The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I (general controls) and Class II (special controls). Their lighting systems are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.

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

Catalogue15

Newest first, rows 1-15 of 15

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  • Model 0450000, Opal Medical Exam Light Ref K893808

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

  • Model 0183010, Pearl Medical Exam Light Ref K893807

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

  • Visionary 2000 Ref K000639

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

  • Genesis Ref K942553

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

  • Basic Light Ref K861289

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

  • Genie' Single Ceiling And Double Ceiling Ref K963682

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

  • Saturn Light Ref K935102

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

  • Outpatient Iii Minor Surgery Light Ref K042395

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

  • Aim 200, Major Surgical Light Ref K101537

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

  • Halux Tasklight Ref K931645

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

  • Wave Fluorescent Magnifier Ref K936088

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

  • Medical Examination Lights Ref K851742

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

  • Pl Exam Light Ref K860088

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

  • Light, Head, Examination Ref K901706

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

  • Genie Ref K961843

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

Rows 1-15 of 15

FDA recalls1

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

FDA recall records list 1 recall initiated by Burton Medical Products Corp., initiated on 2004-02-19. 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.

  • 2004

    • 19 Feb 2004 Z-0589-04 Unclassified (pre-2012) Terminated Pivot joint on these ceiling mount lights may fail and lights may fall onto patients. Distribution: Nationwide. Submission number: K851742

Frequently asked questions

How many devices does Burton Medical Products Corp. have in the registry?

The registry currently lists 15 devices for Burton Medical Products Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Burton Medical Products Corp.'s devices?

Among its 15 most recently registered devices, Burton Medical Products Corp. has devices listed in FDA 510(k) (15 devices).

What risk classes do Burton Medical Products Corp.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Burton Medical Products Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Burton Medical Products Corp.?

FDA recall records list 1 recall initiated by Burton Medical Products Corp., the most recent initiated on 19 Feb 2004. 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 Burton Medical Products Corp. in the registry?

The most recently registered devices listed for Burton Medical Products Corp. include MODEL 0450000, OPAL MEDICAL EXAM LIGHT, MODEL 0183010, PEARL MEDICAL EXAM LIGHT, VISIONARY 2000 and GENESIS.

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