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 |
|---|---|---|---|
| Aug 24, 2006 | K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| Jul 10, 2006 | K053554 | COMPUFLO Milestone Scientific, Inc. | FRN |
| May 22, 2006 | K061128 | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. | FRN |
| May 12, 2006 | K060479 | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| Apr 21, 2006 | K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc. | FRN |
| Apr 17, 2006 | K052817 | EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF Universal Medical Technologies | FRN |
| Apr 12, 2006 | K060119 | MCKINLEY SATURATION CATHETER Mckinley Medical, LLC | FRN |
| Feb 10, 2006 | K052594 | WILLCARE, MODEL GW-1020 Icu Medical, Inc. | FRN |
| Jan 31, 2006 | K053226 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER Zimmer, Inc. | FRN |
| Dec 8, 2005 | K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP Sorenson Medical, Inc. | FRN |
| Nov 23, 2005 | K052218 | CRONO FIVE AND CRONO PCA 50 Cane S.R.L., IT | FRN |
| Nov 23, 2005 | K050800 | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS Caesarea Medical Electronics , Ltd., IL | FRN |
| Nov 17, 2005 | K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP Smiths Medical MD, Inc. | FRN |
| Oct 20, 2005 | K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products | FRN |
| Oct 13, 2005 | K052171 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE Zimmer, Inc. | FRN |
| Sep 13, 2005 | K052219 | CRONO GO. Cane S.R.L., IT | FRN |
| Sep 13, 2005 | K052217 | CRONO SUPER PID Cane S.R.L., IT | FRN |
| Aug 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 Hospira, Inc. | FRN |
| Aug 2, 2005 | K051045 | SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 Spectrx, Inc. | FRN |
| May 27, 2005 | K051252 | MICROPUMP MP-101 Micrel Medical Devices S.A., GR | FRN |
| May 10, 2005 | K043466 | PAINPUMP2 Stryker Instruments | FRN |
| Apr 27, 2005 | K050324 | INFPUMP INFILTRATION PUMP Carolina Medical, Inc. | FRN |
| Apr 14, 2005 | K050474 | VEINNOVATIONS INFILTRATION SYSTEM Veinnovations, LLC | FRN |
| Apr 13, 2005 | K050433 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM Zimmer Orthopaedic Surgical Products | FRN |
| Mar 30, 2005 | K043204 | SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP Sgarlato Laboratories, Inc. | FRN |
| Mar 29, 2005 | K043600 | MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C Medtronic Minimed | FRN |
| Mar 25, 2005 | K043590 | SE INFUSION SYSTEM WITH MMS Cardinal Health, Alaris Products | FRN |
| Mar 24, 2005 | K050301 | MRIDIUM 3850 MRI PUMP SYSTEM Iradimed Corporation | FRN |
| Mar 11, 2005 | K042696 | BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| Feb 11, 2005 | K050107 | HARVARD 2 SYRINGE PUMP, MODEL 2001-001 Harvard Clinical Technology | FRN |
| Jan 4, 2005 | K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 Medex, Inc. | FRN |
| Nov 30, 2004 | K040985 | PUMP CONNECTIVITY INTERFACE Baxter Healthcare Corp | FRN |
| Nov 17, 2004 | K042980 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE Hospira, Inc. | FRN |
| Nov 8, 2004 | K042228 | BEELINE MOTIV, PROPOLIS, PCA Mckinley, Inc. | FRN |
| Oct 14, 2004 | K042405 | PAINPUMP1; PAINPUMP2 Stryker Corp. | FRN |
| Oct 6, 2004 | K042609 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc. | FRN |
| Oct 1, 2004 | K041714 | E-PAIN CARE Breg, Inc. | FRN |
| Sep 17, 2004 | K042085 | CRONO F Cane S.R.L. | FRN |
| Aug 26, 2004 | K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl. | FRN |
| Aug 24, 2004 | K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. | FRN |
| Jul 9, 2004 | K041738 | BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) Baxter Healthcare Corporation | FRN |
| Jul 8, 2004 | K041414 | CRONO AND CRONO, MODEL 30 Cane S.R.L. | FRN |
| Jul 6, 2004 | K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 Alaris Medical Systems, Inc. | FRN |
| Jun 30, 2004 | K041550 | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Abbott Laboratories | FRN |
| Jun 25, 2004 | K041191 | COLLEAGUE VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp | FRN |
| Jun 3, 2004 | K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP Byron Medical | FRN |
| May 24, 2004 | K041152 | THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A Applied Diabetes Research, Inc. | FRN |
| Apr 30, 2004 | K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Apr 8, 2004 | K040061 | MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C Medtronic Minimed | FRN |
| Jan 29, 2004 | K040114 | ABBOTT DATA PORT PC, MODEL 12181 Abbott Laboratories | FRN |
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