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Phasor Health, LLC

United StatesFDA applicant, unverified FDA FEI 3016577622

Devices
99
Registrations
FDA
FDA recalls
11 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Phasor Health, LLC makes

Phasor Health, LLC manufactures single-use neurosurgical tools, including medicated procedure kits, battery-powered craniotomy systems, and automatic cranial perforators. Their portfolio also includes cranial trephines, non-bioabsorbable skin staplers, electromagnetic spatial tracking markers, and cerebrospinal fluid drainage kits designed for surgical applications.

All listed devices fall under FDA Class II regulation and are authorised via 510(k) clearance and the FDA’s Unique Device Identification (UDI) system. The company’s products are registered in the FDA’s regulatory databases, and the manufacturer is based in the United States.

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

Catalogue99

Newest first, rows 1-50 of 99

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  • Phasor 11.0l Open recall

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

  • Phasor 11.0S Open recall

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

  • Phasor 14.0S Open recall

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

  • Phasor 14.0l Open recall

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

  • Phasor 2-In-1 Open recall

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

  • Phasor 2-In-1-05CK

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1-25K

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1-25LKX

    Listed Registry: GUDID Class:I

  • Phasor 2-In-1-25LK

    Listed Registry: GUDID Class:I

  • Phasor 2-In-1-26 Open recall

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

  • Phasor 2-In-1-45LK

    Listed Registry: GUDID Class:I

  • Phasor 3-In-1-245K

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1-26K

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1-45CK

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1K

    Listed Registry: GUDID Class:II

  • Phasor 2-In-1-26LK

    Listed Registry: GUDID Class:I

  • Phasor 2-In-1-45K

    Listed Registry: GUDID Class:II

  • Phasor 3-In-1-246K

    Listed Registry: GUDID Class:II

  • Phasor 3-In-1-246LK

    Listed Registry: GUDID Class:I

  • Phasor 3-In-1-256CK

    Listed Registry: GUDID Class:II

  • Phasor 3-In-1-256K

    Listed Registry: GUDID Class:—

  • Phasor 3-In-1-256LK

    Listed Registry: GUDID Class:I

  • Phasor 3-In-1-45RK

    Listed Registry: GUDID Class:II

  • Phasor 4-In-1-2456K

    Listed Registry: GUDID Class:II

  • Phasor 4-In-1K

    Listed Registry: GUDID Class:II

  • Phasor 4-In-1LK

    Listed Registry: GUDID Class:I

  • Phasor 5-In-1LK

    Listed Registry: GUDID Class:I

  • Phasor 6.35CK

    Listed Registry: GUDID Class:II

  • Phasor 8.40l Open recall

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

  • Phasor 8.40S Open recall

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

  • Phasor Evac-Mri

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

  • Phasor Gre.dba

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

  • Phasor Gre.dri

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

  • Phasor Ph-240-70-S Open recall

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

  • Phasor Ph-450-70-D + Ph-K-A Open recall

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

  • Phasor Ph-240-210 + Ph-K-2 Open recall

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

  • Phasor Ph-270-70 + Ph-K-2 Open recall

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

  • Phasor Ph-450-70 + Ph-K-1 Open recall

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

  • Phasor Ph-270-70 + Ph-K-1 Open recall

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

  • Phasor Ph-635-70-D + Ph-K-A1S Open recall

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

  • Phasor Ph-270-70-S Open recall

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

  • Phasor Ph-270-70 + Ph-K-A Open recall

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

  • Phasor Ph-270-70-S + Ph-K-A

    Listed Registry: GUDID Class:—

  • Phasor Ph-635-70-D + Ph-K-A Open recall

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

  • Phasor 2.70S Open recall

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

  • Phasor Ph-450-70-D + Ph-K-1 Open recall

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

  • Phasor Ph-450-70-D + Ph-K-A1 Open recall

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

  • Phasor 2.10l Open recall

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

  • Phasor Ph-270-210 Open recall

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

  • Phasor Ph-450-70-Dt Open recall

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

Rows 1-50 of 99

Showing 1-50 of 99

Company details

FDA FEI number
3016577622
DUNS number
111926675
Address
8944 Kirby Drive, Houston, TX, 77054
Phone
8329821234

FDA recalls1

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

FDA recall records list 1 recall initiated by Phasor Health, LLC, initiated on 2025-03-21. By recorded status: 1 ongoing. The reasons filed fall into these groups: electrical or power. 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 0

  • 2025

    • 21 Mar 2025 Z-2192-2025 Class II Ongoing Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. Distribution: US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT Submission number: K161704

Frequently asked questions

How many devices does Phasor Health, LLC have in the registry?

The registry currently lists 99 devices for Phasor Health, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Phasor Health, LLC's devices?

Among its 50 most recently registered devices, Phasor Health, LLC has devices listed in FDA GUDID (50 devices).

What risk classes do Phasor Health, LLC's devices fall under?

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

Are there FDA recall records for Phasor Health, LLC?

FDA recall records list 1 recall initiated by Phasor Health, LLC, the most recent initiated on 21 Mar 2025. 1 of them is recorded as ongoing. 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 Phasor Health, LLC in the registry?

The most recently registered devices listed for Phasor Health, LLC include PHASOR 11.0L, PHASOR 11.0S, PHASOR 14.0S and PHASOR 14.0L.

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