Myriad Ultrasound Systems , Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Myriad Ultrasound Systems , Ltd.”, plus 1 PMA decision, across 1 product code in 1 review panel. 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 |
|---|---|---|---|
| MUA | Bone Sonometer | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970026 | PMA | MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN | 1998-05-29 |
Recalls
openFDA lists no recalls under a recalling firm named Myriad Ultrasound Systems , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Myriad Lase, Inc. (4 510(k)s)
- Myriad Medical, LLC (1 510(k)s)
- Myriad Genetic Laboratories, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Myriad Ultrasound Systems , Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Myriad Ultrasound Systems , Ltd.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Myriad Ultrasound Systems , Ltd.?
The most frequent FDA product codes under this applicant name are MUA (Bone Sonometer, 1).
Next steps
- See all 0 Myriad Ultrasound Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MUA, Myriad Ultrasound Systems , Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.