FDA applicant
Safe Obstetric Systems, Ltd.
FDA records 1 decision for Safe Obstetric Systems, Ltd. (Shenfield, GB) in 2017: 1 De Novo grant. All are in product code PWB (Fetal Head Elevator). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Safe Obstetric Systems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Safe Obstetric Systems, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Safe”
FDA records each applicant name separately; these may or may not be the same firm.