Company
Zevex International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
27recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 CMS Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4176, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4169, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4168, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4167, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4164, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4162, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4144, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4137, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4134, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administrat Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4130, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administrat Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4128, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4127, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4126, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4114, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4111, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4175, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | K981816 |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4119, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | K981816 |
| Sep 21, 2009 | Zevex International, Inc. Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. Terminated |
LZH | K031199 |
| Sep 21, 2009 | Zevex International, Inc. EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
A rotary peristaltic pump designed to deliver programmed doses of enteral nut Terminated |
LZH | K031199 |