Safe Obstetric Systems, Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Safe Obstetric Systems, Ltd.”, plus 1 De Novo 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 |
|---|---|---|---|
| PWB | Fetal Head Elevator | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150053 | De Novo | Fetal Head Elevator | 2017-07-27 |
Recalls
openFDA lists no recalls under a recalling firm named Safe Obstetric 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.
- Safe Orthopaedics (13 510(k)s)
- Safe Glove , Ltd. (2 510(k)s)
- Safe Secure Packaging Co., Ltd. (2 510(k)s)
- Safe Shield Co., Ltd. (2 510(k)s)
- Safe Tech Medical Products, Inc. (2 510(k)s)
- Safe Bvm Corporation (1 510(k)s)
- Safe Medical Design (1 510(k)s)
- Safe Product Supplies (1 510(k)s)
- Safe Restraints, Inc. (1 510(k)s)
- Safe Secure Packing Co., Ltd. (1 510(k)s)
- Safe Sun Corporation of America, Inc. (1 510(k)s)
- Safe T Medical Devices, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Safe Obstetric Systems, Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Safe Obstetric Systems, Ltd.”, plus 1 De Novo 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 Safe Obstetric Systems, Ltd.?
The most frequent FDA product codes under this applicant name are PWB (Fetal Head Elevator, 1).
Next steps
- See all 0 Safe Obstetric Systems, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PWB, Safe Obstetric 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.