Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage in Terminated |
FRN | K100704 |
| Mar 8, 2011 | Hospira Inc Hospira Power cord use on Symbiq One-Channel infuser and
Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07.
Used on List No. 16026 - Symbiq One Channel infuser;
List No. 16027 - Symbiq T Terminated |
FRN | K051550 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL3 Micro/Macro with DataPort Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11855 Terminated |
FRN | K952799 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11845 Terminated |
FRN | K952799 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL3 Infusion Pump, Triple Channel; list number 11781 Terminated |
FRN | K931375 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859 Terminated |
FRN | K010924 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846 Terminated |
FRN | K952799 |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL Infusion Pump, Single Channel; list number 11555 Terminated |
FRN | K953660 |
| 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 |
| Feb 18, 2011 | Baxter Healthcare Corp. InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes inc Terminated |
FRN | K883577 |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161.
Intended for use i Terminated |
FRN | K063696 |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161 Terminated |
FRN | K063696 |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063
For delivery of intravenous solutions, drug solutions, enteral feedings Terminated |
FRN | K915522 |
| Jan 10, 2011 | B Braun Medical, Inc Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets Terminated |
FRN | K011975 K994375 |
| Nov 17, 2010 | Angiodynamics, INC Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. Terminated |
FRN | K951814 |
| Nov 17, 2010 | Angiodynamics, INC LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. Terminated |
FRN | K905839 K905840 +3 |
| Nov 17, 2010 | Angiodynamics, INC Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Terminated |
FRN | K010767 |
| Nov 17, 2010 | Angiodynamics, INC Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Terminated |
FRN | K032557 |
| Nov 17, 2010 | Angiodynamics, INC Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Terminated |
FRN | K010189 |
| Nov 5, 2010 | Sigma International General Medical Apparatus, Llc Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --
Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 - Terminated |
FRN | K042121 |
| Nov 5, 2010 | Walkmed Infusion LLC WalkMed Triton Pole Mount Infusion Pump, Catalog 300000.
Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia. Terminated |
FRN | K070529 |
| Oct 22, 2010 | Hospira Inc Hospira brand Symbiq Two-Channel Infuser,
LIST No. 16027 Symbiq Two-Channel Infuser,
List Number Configurations:
16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90,
1 Terminated |
FRN | K041550 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.