Hubinger Co.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Hubinger Co.”, plus 1 PMA decision, across 1 product code. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGP | 1 | 0 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N85356 | PMA | ABSORBABLE DUSTING POWDER | 1978-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Hubinger Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hubinger Co.?
FDA lists 0 510(k) clearances under the applicant name “Hubinger Co.”, plus 1 PMA decision, across 1 product code. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Hubinger Co.?
The most frequent FDA product codes under this applicant name are KGP (device, 1).
Next steps
- See all 0 Hubinger Co. clearances with predicates and recalls
- Run predicate analysis for product code KGP, Hubinger Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.