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International Life Sciences

United Statesfrom the FDA registration address FDA FEI 3010673515

Devices
4
Registrations
FDA
FDA recalls
33 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue4

Newest first, rows 1-4 of 4

  • FlexBand; FlexPatch; FlexBand Plus Ref K230316 Open recall

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

  • ATL Anchors Ref K200503 Open recall

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

  • FlexBand Plus Ref K192112

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

  • Artelon Convenience Kits Ref K260317

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

Company details

FDA FEI number
3010673515
Address
8601 Dunwoody Pl #250, Sandy Springs, GA, 30350
Email
[email protected](from company website)

FDA recalls3

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

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 3

  • 2026

    • 6 Feb 2026 Z-1554-2026 Class II Ongoing Augmentation devices failed bacterial endotoxin testing. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
      Submission numbers: K200503, K230316
    • 6 Feb 2026 Z-1555-2026 Class II Ongoing Augmentation devices failed bacterial endotoxin testing. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
      Submission number: K230316
    • 6 Feb 2026 Z-1556-2026 Class II Ongoing Augmentation devices failed bacterial endotoxin testing. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
      Submission numbers: K200503, K230316

From the company website

Read 18 Oct 2026

Artelon is the leader in dynamic innovations for tendon and ligament injuries. These innovations within our FLEXBAND brand optimize outcomes in treating instability from sprained ankles and other joints.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does International Life Sciences have in the registry?

The registry currently lists 4 devices for International Life Sciences. Devices recorded under merged duplicate company entries are counted once.

Which registries list International Life Sciences's devices?

Among its 4 most recently registered devices, International Life Sciences has devices listed in FDA 510(k) (4 devices).

What risk classes do International Life Sciences's devices fall under?

Among its 4 most recently registered devices, the classes recorded for International Life Sciences's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for International Life Sciences?

FDA recall records list 3 recalls initiated by International Life Sciences, the most recent initiated on 6 Feb 2026. 3 of them are 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 International Life Sciences in the registry?

The most recently registered devices listed for International Life Sciences include FlexBand; FlexPatch; FlexBand Plus, ATL Anchors, FlexBand Plus and Artelon Convenience Kits.

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