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Kalila Medical, Inc.

United StatesFDA applicant, unverified

Devices
8
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Kalila Medical, Inc. makes

Kalila Medical, Inc. manufactures steerable sheaths designed for vascular and interventional procedures, including bi-directional and standard steerable options for catheter navigation.

These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.

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

Catalogue8

Newest first, rows 1-8 of 8

  • Vado SS8FMB74

    Withdrawn Registry: GUDID Class:II

  • Vado SS8FMU67

    Withdrawn Registry: GUDID Class:II

  • Vado SS8FMU67

    Withdrawn Registry: GUDID Class:II

  • CrossWise CW-STS8F25

    Withdrawn Registry: GUDID Class:II

  • Nagare SS8FMB74

    Withdrawn Registry: GUDID Class:II

  • Vado Bi-Directional Steerable Sheath Ref K162427

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

  • Vado Steerable Sheath Ref K160721

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

  • Vado Steerable Sheath Ref K140420

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

Company details

DUNS number
015986592
Phone
+1-800-888-3786

FDA recalls2

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

FDA recall records list 2 recalls initiated by Kalila Medical, Inc., initiated on 2017-12-14. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. 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 2
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2017

    • 14 Dec 2017 Z-0563-2018 Class II Terminated Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process. Distribution: Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government…
      Full distribution text Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.
      Submission number: K160721
    • 14 Dec 2017 Z-0564-2018 Class II Terminated Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process. Distribution: Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government…
      Full distribution text Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.
      Submission number: K162427

Frequently asked questions

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

The registry currently lists 8 devices for Kalila Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kalila Medical, Inc.'s devices?

Among its 8 most recently registered devices, Kalila Medical, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 8 most recently registered devices, the classes recorded for Kalila Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Kalila Medical, Inc.?

FDA recall records list 2 recalls initiated by Kalila Medical, Inc., the most recent initiated on 14 Dec 2017. 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 Kalila Medical, Inc. in the registry?

The most recently registered devices listed for Kalila Medical, Inc. include Vado SS8FMB74, Vado SS8FMU67, CrossWise CW-STS8F25 and Nagare SS8FMB74.

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