Stimwave Technologies, Inc.

Country not established

Devices: 1
FDA recalls: 60 ongoing since 2021 (6 open in total); 6 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Stimwave Technologies, Inc. makes

Stimwave Technologies, Inc. manufactures the SandShark Injectable Anchor (SIA) System, a medical device designed for securing implants or electrodes within soft tissue, such as those used in neuromodulation or orthopedic applications.

The SandShark Injectable Anchor System is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

SandShark Injectable Anchor (SIA) System Ref K191466

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

FDA recalls6

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

FDA recall records list 6 recalls initiated by Stimwave Technologies, Inc., initiated on 2020-07-15. By recorded status: 6 ongoing. The reasons filed fall into these groups: labeling or instructions for use. 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 6
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2020
- 15 Jul 2020 Z-2928-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366
- 15 Jul 2020 Z-2929-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366
- 15 Jul 2020 Z-2930-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366
- 15 Jul 2020 Z-2931-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366
- 15 Jul 2020 Z-2932-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366
- 15 Jul 2020 Z-2933-2020 Class II Open since 2020 The product contains a non-functional component not referenced in product labeling. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
  Submission numbers: K152178, K171366

Frequently asked questions

How many devices does Stimwave Technologies, Inc. have in the registry?

The registry currently lists 1 device for Stimwave Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stimwave Technologies, Inc.'s devices?

Among its 1 most recently registered device, Stimwave Technologies, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Stimwave Technologies, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Stimwave Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stimwave Technologies, Inc.?

FDA recall records list 6 recalls initiated by Stimwave Technologies, Inc., the most recent initiated on 15 Jul 2020. 6 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 Stimwave Technologies, Inc. in the registry?

The most recently registered devices listed for Stimwave Technologies, Inc. include SandShark Injectable Anchor (SIA) System.

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