Medical device manufacturer
Nova Biomedical Corporation
Nova Biomedical Corporation holds 129 FDA 510(k) clearances across 32 product codes. Median elapsed review time is 78 days. openFDA lists 36 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 129
- Product codes
- 32
- Median review
- 78 days
- Recall records
- 36
How does FDA spell Nova Biomedical Corporation?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| NOVA BIOMEDICAL CORPORATION | device/registrationlisting | normalised |
| Nova Biomedical Corp. | device/510k | normalised |
| Nova Biomedical Corporation | device/registrationlisting | normalised |
| Nova Biomedical Corporation | device/enforcement | normalised |
| Nova Biomedical Corporation | device/510k | normalised |
| Nova Biomedical Corporation | device/recall | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Nova Biomedical Corporation file in?
32 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 28 | 66 days | |
| JGS | Electrode, Ion Specific, Sodium | 21 | 61 days | |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 10 | 87 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 | 78 days | |
| CGA | Glucose Oxidase, Glucose | 7 | 77 days | |
| JFP | Electrode, Ion Specific, Calcium | 6 | 59 days | |
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 182 days | |
| CEM | Electrode, Ion Specific, Potassium | 4 | 73 days | |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 3 | 57 days | |
| GKF | Instrument, Hematocrit, Automated | 3 | 26 days | |
| KHP | Acid, Lactic, Enzymatic Method | 3 | 443 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 179 days | |
| CGZ | Electrode, Ion-Specific, Chloride | 2 | 56 days | |
| GGZ | Oxyhemoglobin | 2 | 69 days | |
| GLY | Oximeter To Measure Hemoglobin | 2 | 77 days | |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 | 21 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 90 days | |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 | 71 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 17 days | |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 132 days | |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 41 days | |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 126 days | |
| GJS | Test, Time, Prothrombin | 1 | 39 days | |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 81 days | |
| GKZ | Counter, Differential Cell | 1 | 77 days |
Showing the 25 they file in most, of 32.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Nova Biomedical Corporation had a recall?
openFDA lists 36 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0681-2025Class IOpen, ClassifiedPZI
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Z-0682-2025Class IOpen, Classified
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Z-0683-2025Class IOpen, Classified
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Z-0207-2024Class IIOpen, ClassifiedJGS
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
Z-0208-2024Class IIOpen, ClassifiedJGS
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
Showing the 5 most recently initiated of 36.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Nova Biomedical Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | SHB | 272 | |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 179 | |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | LCP | 931 | |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 881 | |
| K232075 | StatStrip Glucose Hospital Meter System | PZI | 226 | |
| K221900 | Stat Profile Prime Plus Analyzer System | CHL | 456 | |
| K203549 | Nova Primary Glucose Analyzer System | CGA | 683 | |
| K200403 | Stat Profile Prime Plus Analyzer System | JGS | 55 | |
| K200204 | Stat Profile Prime Plus Analyzer System | GGZ | 69 | |
| K200349 | Stat Profile Prime Plus Analyzer System | CGA | 30 |
Source: openFDA device/510k · retrieved
Where is Nova Biomedical Corporation registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Nova Biomedical Corporation files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.