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Solstice Corp.

Also registered as SOLSTICE CORPORATION

Country not established

Solstice Corp. is a medical device manufacturer, with 16 devices listed in FDA GUDID and FDA 510(k) (FDA Class I) and 1 FDA recall as of 14 Nov 2026.

Devices
16
FDA recalls
11 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 15
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class I 16
FDA recalls

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Solstice Corp. makes

Solstice Corp. manufactures single-use imaging lesion localization markers for external placement, manual radiographic image markers, and general-purpose absorbent tip applicators/swabs. Their product line includes the Xact marker and the Micro-Tip applicator, designed for precise localization and procedural support in medical imaging and diagnostics.

The company’s devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States, where Solstice Corp. is based.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices
Skip device list

  • Xact M15S

    Listed Registry: GUDID Class:I

  • Xact M10R

    Listed Registry: GUDID Class:I

  • Xact M10AC

    Listed Registry: GUDID Class:I

  • Xact M10LM

    Listed Registry: GUDID Class:I

  • Xact M20S

    Listed Registry: GUDID Class:I

  • Xact M15R

    Listed Registry: GUDID Class:I

  • Xact M23SC

    Listed Registry: GUDID Class:I

  • Xact M15RM

    Listed Registry: GUDID Class:I

  • Xact M15RT

    Listed Registry: GUDID Class:I

  • Xact M10TM

    Listed Registry: GUDID Class:I

  • Micro-Tip A28PC

    Listed Registry: GUDID Class:I

  • Xact M15SC

    Listed Registry: GUDID Class:I

  • Xact M10LT

    Listed Registry: GUDID Class:I

  • Xact M10TT

    Listed Registry: GUDID Class:I

  • Xact M20SC

    Listed Registry: GUDID Class:I

  • Solstice Xray Ring Marker Pad Ref K925892

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

Rows 1-16 of 16

FDA recalls1

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

Recalls initiated per year

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

  • 2026

    • 22 Sep 2026 Z-0268-2027 Not yet classified Ongoing The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. Distribution: Worldwide - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and…
      Full distribution text Worldwide - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico. The country of Canada.

Frequently asked questions

How many devices does Solstice Corp. have in the registry?

The registry currently lists 16 devices for Solstice Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Solstice Corp.'s devices?

Among its 16 most recently registered devices, Solstice Corp. has devices listed in FDA 510(k) (1 device) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Solstice Corp.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Solstice Corp.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Solstice Corp.?

FDA recall records list 1 recall initiated by Solstice Corp., the most recent initiated on 22 Sep 2026. 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 Solstice Corp. in the registry?

The most recently registered devices listed for Solstice Corp. include Xact M15S, Xact M10R, Xact M10AC and Xact M10LM.

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