Company ยท US
Apogee Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2004. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2011 | Apogee Medical, Inc Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag).
Intended usage: Kit components to be used during Intermittent Urina Terminated |
OHR | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheteriz Terminated |
KMJ | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the b Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |