Nova Medical Specialties: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Nova Medical Specialties” (first 1981, latest 1987), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 93 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYG | Catheter, Flow Directed | 7 | 7 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| KRG | Programmer, Pacemaker | 1 | 1 |
Review panels
- Cardiovascular (11)
Most recent Nova Medical Specialties 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872770 | DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. | DYG | 1987-10-15 | 93 |
| K860526 | NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH | DXO | 1986-05-02 | 80 |
| K853625 | NOVA ARTERIAL EMBOLECTOMY CATHETER | DXE | 1986-01-15 | 139 |
| K840009 | NOVA 12 CARDIAC OUTPUT COMPUTER | DXG | 1984-08-22 | 231 |
| K841640 | NOVA BALLOON THERMODILUTION INFUSION | DYG | 1984-08-12 | 114 |
| K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | 1984-08-12 | 114 |
| K834037 | HEPARIN COATED BALLOON THERMODILU | DYG | 1984-01-10 | 48 |
| K834036 | HEPARIN COATED BALLOON THERMODILU | DYG | 1984-01-10 | 48 |
| K832287 | NOVA BALLOON THERMODILUTION INFUSION | DYG | 1983-10-19 | 98 |
| K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | 1982-11-01 | 45 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nova Medical Specialties.
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.
- Nova Biomedical Corp. (129 510(k)s)
- Nova Health Systems, Inc. (3 510(k)s)
- Nova Technology Corp. (3 510(k)s)
- Nova Corp. (1 510(k)s)
- Nova Design Technologies, Ltd. (1 510(k)s)
- Nova Diversified Concepts (1 510(k)s)
- Nova Eye, Inc. (1 510(k)s)
- Nova Eye Inc. (Business Name Nova Eye Medical) (1 510(k)s)
- Nova Health Concepts, Inc. (1 510(k)s)
- Nova Implants , Ltd. (1 510(k)s)
- Nova Medical, Inc. (1 510(k)s)
- Nova Ortho-Med, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nova Medical Specialties?
FDA lists 11 510(k) clearances under the applicant name “Nova Medical Specialties” (first 1981, latest 1987), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nova Medical Specialties?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nova Medical Specialties is 93 days.
Which FDA product codes appear under Nova Medical Specialties?
The most frequent FDA product codes under this applicant name are DYG (Catheter, Flow Directed, 7); DXE (Catheter, Embolectomy, 1); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1).
Next steps
- See all 11 Nova Medical Specialties clearances with predicates and recalls
- Run predicate analysis for product code DYG, Nova Medical Specialties'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.