Confluent Medical Technologies, Inc — FDA Facility Profile
Confluent Medical Technologies, Inc is an FDA-registered facility (FEI 3007635982) located in Fremont, CA, US. RegDataLab tracks 5 FDA inspections at this facility.
Reviewing Confluent Medical Technologies, Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Confluent Medical Technologies, Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Aug 15, 2017: No Action Indicated (NAI)
- Inspections on record
- 5 (5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest May 28, 2014
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 15, 2017 | No Action Indicated (NAI) | No citations listed |
| Apr 11, 2016 | No Action Indicated (NAI) | No citations listed |
| Jan 16, 2014 | No Action Indicated (NAI) | No citations listed |
| May 22, 2012 | No Action Indicated (NAI) | No citations listed |
| Jun 11, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 28, 2014 | Class I | Z-1812-2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating… and 11 more products Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
Facility details
- Company
- Confluent Medical Technologies, Inc.
- Location
- Fremont, CA (US)
- Source
- device