Company ยท US
Nephron Pharmaceuticals Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2023. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2023 | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) Nephron Pharmaceuticals Corporation | LZA |
| Jun 19, 2012 | K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML Nephron Pharmaceuticals Corp. | CAF |
| Apr 20, 2012 | K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML Nephron Pharmaceuticals Corp. | CAF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for Terminated |
CAF | K120051 |
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as Terminated |
CAF | K120051 |
| May 29, 2013 | Nephron Pharmaceuticals Corp. EZ Breathe Medication Cup.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |
| May 29, 2013 | Nephron Pharmaceuticals Corp. AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |
| May 29, 2013 | Nephron Pharmaceuticals Corp. EZ Breathe Atomizer Model # EZ-100.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |