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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2014 | K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation | FRN |
| Oct 17, 2013 | K123049 | SAPPHIRE INFUSION PUMP Q Core Medical , Ltd. | FRN |
| Sep 27, 2013 | K123822 | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET Hk Surgical, Inc. | FRN |
| Jun 12, 2013 | K130690 | Z-800 INFUSION SYSTEM Zyno Medical, LLC | FRN |
| May 1, 2013 | K121613 | AGILIA INFUSION SYSTEM Fresenius Kabi AG | FRN |
| Mar 13, 2013 | K124053 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. | FRN |
| Feb 1, 2013 | K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc. | FRN |
| Oct 26, 2012 | K122215 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. | FRN |
| Apr 16, 2012 | K120830 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. | FRN |
| Mar 26, 2012 | K110535 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION Carefusion 303, Inc. | FRN |
| Mar 5, 2012 | K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc. | FRN |
| Sep 16, 2011 | K112067 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. | FRN |
| Aug 29, 2011 | K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc. | FRN |
| Jul 11, 2011 | K101194 | NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 Carticept Medical, Inc. | FRN |
| Jul 8, 2010 | K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 Zyno Medical, LLC | FRN |
| Jun 23, 2010 | K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C Medrad, Inc. | FRN |
| May 14, 2010 | K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE Disetronic Medical Systems AG | FRN |
| Dec 9, 2009 | K093332 | DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) Delphi Medical Systems | FRN |
| Oct 30, 2009 | K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET Synergetics, Inc. | FRN |
| Oct 2, 2009 | K091386 | MICROFUSE DUAL RATE INFUSER Numia Medical Technology, LLC | FRN |
| Jul 9, 2009 | K091308 | ALARIS PC UNIT, MODELS 8000 AND 8015 Cardinal Health 303,Inc. | FRN |
| Jul 1, 2009 | K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 Belmont Instrument Corp. | FRN |
| Jul 1, 2009 | K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B.Braun Medical, Inc. | FRN |
| May 20, 2009 | K090736 | POWER INFUSER, MODEL M100B-3A ZOLL Medical Corporation | FRN |
| May 12, 2009 | K091042 | CRONO S-PID 50 Cane S.R.L., IT | FRN |
| Apr 7, 2009 | K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM Iradimed Corporation | FRN |
| Dec 17, 2008 | K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. | FRN |
| Oct 23, 2008 | K072603 | ABC SYRINGE INFUSION PUMP, MODEL 4100 Elixir Corporation | FRN |
| Oct 22, 2008 | K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE Hospira, Inc. | FRN |
| Aug 15, 2008 | K082182 | AP 34 MULTI-THERAPY INFUSION PUMP Q-Core, Ltd., IL | FRN |
| Jun 17, 2008 | K080297 | MEDRAD INTEGO PET INFUSION SYSTEM Medrad, Inc. | FRN |
| May 30, 2008 | K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY Medrad, Inc. | FRN |
| May 16, 2008 | K080954 | T34L SYRINGE DRIVER Caesarea Medical Electronics , Ltd., IL | FRN |
| Apr 25, 2008 | K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP Smiths Medical MD, Inc. | FRN |
| Dec 28, 2007 | K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX Cardinal Health 303,Inc. | FRN |
| Nov 26, 2007 | K071588 | DISPENSER DP 20 NOUVAG AG, CH | FRN |
| Oct 31, 2007 | K071545 | Z-800 VOLUMETRIC INFUSION PUMP Zyno Medical, LLC | FRN |
| May 18, 2007 | K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| May 8, 2007 | K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP Definitive Medical Technologies, Ltd., IL | FRN |
| Apr 24, 2007 | K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc. | FRN |
| Apr 16, 2007 | K070125 | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION Baxter Healthcare Corp | FRN |
| Apr 13, 2007 | K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| Feb 27, 2007 | K063696 | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 Baxterhealthcare, Inc. | FRN |
| Feb 23, 2007 | K070268 | SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X Cardinal Health 303,Inc. | FRN |
| Feb 2, 2007 | K061108 | STRYKER AUTO IRRIGATION SYSTEM Stryker | FRN |
| Jan 25, 2007 | K052973 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K Baxter Healthcare Corp | FRN |
| Nov 29, 2006 | K062592 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE Smiths Medical MD, Inc. | FRN |
| Nov 28, 2006 | K063288 | SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X Cardinal Health 303,Inc. | FRN |
| Oct 26, 2006 | K062700 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B.Braun Medical, Inc. | FRN |
| Oct 26, 2006 | K062699 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B.Braun Medical, Inc. | FRN |
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