Data / Medical devices / United States / Avertix Medical Inc.
Avertix Medical Inc.: FDA-registered device maker in Eatontown, NJ, United States, 1 PMA approval
Avertix Medical Inc. is registered with the FDA (registration 3017374019) in Eatontown, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 9, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017374019
- Address
- 40 Christopher Way, Suite 201, Eatontown, NJ, United States, 07724
- Owner or operator
- Avertix Medical Inc. (10079576)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 14, 2020
- Registered through
- 2026
- Brand names listed
- The Guardian System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acute Coronary Syndrome Event Detector | QBI | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | P150009 | Guardian System | QBI | 12 | August 14, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 1, 2023 | 96126 | Class II | Ongoing | Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patien | Device reaching End of Service prematurely. | accessdata.fda.gov |
Updated February 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.