Company ยท US
Medefil, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2012. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2012 | K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY Medefil, Inc. | NGT |
| Feb 3, 2010 | K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES Medefil, Inc. | NZW |
| Jan 28, 2010 | K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE Medefil, Inc. | NGT |
| Jun 24, 2002 | K020996 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL Medefil, Inc. | NGT |
| Jun 20, 2002 | K020999 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL Medefil, Inc. | NGT |
| Jun 12, 2000 | K993518 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL Medefil, Inc. | FOZ |
| Feb 25, 2000 | K993515 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L Medefil, Inc. | FOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2014 | Medefil Incorporated Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. Terminated |
NZW | K092491 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | K092491 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | K092491 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V Terminated |
NZW | K092491 |
| May 9, 2008 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. F Terminated |
NZW | None listed |
| May 9, 2008 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | None listed |
| May 9, 2008 | Medefil Incorporated Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V Terminated |
NZW | None listed |