Argo Medical Technologies, Inc.: FDA clearances and approvals
Argo Medical Technologies, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. openFDA lists 2 product recalls by a recalling firm named Argo Medical Technologies, Inc.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHL | Powered Exoskeleton | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130034 | De Novo | Powered Exoskeleton | 2014-06-26 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-02-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Argo Medical Technologies, Inc. have?
Argo Medical Technologies, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Argo Medical Technologies, Inc. make?
Its most frequent FDA product codes are PHL (Powered Exoskeleton, 1).
Has Argo Medical Technologies, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Argo Medical Technologies, Inc; the most recent began 2020-02-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Argo Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PHL, Argo Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.