FDA applicant
Neonatal Corp.
FDA records 3 decisions for Neonatal Corp. (Mchenry, IL) in 1981: 3 510(k) clearances. Most are in product codes HFS (Shield, Nipple) and GDX (Scalpel, One-Piece). 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 Neonatal Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Neonatal Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Neonatal Corp.’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 “Neonatal”
FDA records each applicant name separately; these may or may not be the same firm.