FDA applicant
Nova Biomedical Corp.
FDA records 129 decisions for Nova Biomedical Corp. (Walham, MA) from 1977 to 2026: 129 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and JGS (Electrode, Ion Specific, Sodium). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 46 of them its own earlier devices. 30 recalls are linked to its devices, 13 Class I.
FDA’s records also spell it “Nova Biomedical Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nova Biomedical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Nova Biomedical 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 “Nova”
FDA records each applicant name separately; these may or may not be the same firm.