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 |
|---|---|---|---|
| Jan 14, 2004 | K030739 | INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE Infusion Dynamics, Inc. | FRN |
| Nov 6, 2003 | K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP Sorenson Medical, Inc. | FRN |
| Nov 6, 2003 | K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP Sorenson Medical, Inc. | FRN |
| Oct 9, 2003 | K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 American I.V. Products, Inc. | FRN |
| Sep 23, 2003 | K032771 | MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. | FRN |
| Sep 23, 2003 | K032642 | BEELINE SYSTEM Mckinley, Inc. | FRN |
| Aug 22, 2003 | K032005 | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 Medtronic Minimed | FRN |
| Aug 21, 2003 | K031749 | BODYGUARD INFUSION SYSTEM Caesarea Medical Electronics , Ltd., IL | FRN |
| Aug 13, 2003 | K031600 | CONDUCTION CATHETER Micor, Inc. | FRN |
| Aug 7, 2003 | K031432 | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II Hk Surgical, Inc. | FRN |
| Jul 25, 2003 | K032147 | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES Alaris Medical Systems, Inc. | FRN |
| Jul 21, 2003 | K031249 | MODIFICATION TO STRYKER PAINPUMP Stryker Instruments | FRN |
| May 21, 2003 | K030576 | ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II The Anspach Effort, Inc. | FRN |
| Apr 30, 2003 | K031185 | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE Abbott Laboratories | FRN |
| Apr 18, 2003 | K030885 | MODIFICATION TO STRYKER PAINPUMP2 Stryker Instruments | FRN |
| Apr 4, 2003 | K030459 | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) Alaris Medical Systems, Inc. | FRN |
| Apr 2, 2003 | K030323 | MRI-CADDY Mammendorfer Institute For Physics & Medicine GmbH | FRN |
| Mar 20, 2003 | K023189 | VISTA BASIC WITH FM SYSTEM B.Braun Medical, Inc. | FRN |
| Mar 17, 2003 | K024190 | FENESTRATED INFUSION CATHETER Promedic, Inc. | FRN |
| Feb 28, 2003 | K023083 | SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 Mettler Electronics Corp. | FRN |
| Feb 27, 2003 | K023973 | AUTOMED 3200 INFUSION PUMP Help Technologies | FRN |
| Feb 7, 2003 | K023863 | AUTOMED 3000 INFUSION PUMP Help Technologies | FRN |
| Jan 17, 2003 | K024056 | SURESET 3.0 ML RESERVOIR, MODEL 24-103 Applied Diabetes Research, Incorporated | FRN |
| Dec 31, 2002 | K024084 | ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 Abbott Laboratories | FRN |
| Dec 19, 2002 | K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc. | FRN |
| Dec 13, 2002 | K023827 | PARAGON INFUSION SYSTEM WITH BOLUS I-Flow Corp. | FRN |
| Dec 13, 2002 | K023491 | AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM Help Technologies | FRN |
| Sep 30, 2002 | K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT Abbott Laboratories, Inc. | FRN |
| Sep 20, 2002 | K022869 | SOAKER CATHETER I-Flow Corp. | FRN |
| Aug 29, 2002 | K021988 | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM Medrad, Inc. | FRN |
| Aug 21, 2002 | K022575 | PERFUSOR COMPACT WITH FM SYSTEM B.Braun Medical, Inc. | FRN |
| May 14, 2002 | K021350 | ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 Abbott Laboratories | FRN |
| May 14, 2002 | K013840 | MICROJET CRONO PAR AND CRONO APO-GO Cane S.R.L. | FRN |
| May 9, 2002 | K013855 | MICROJET CRONO H Cane S.R.I. | FRN |
| Apr 26, 2002 | K013776 | MICROJET MODEL # CD4 AND CD4/20 Cane S.R.I. | FRN |
| Apr 26, 2002 | K013234 | MICROJET CRONO Cane S.R.L. | FRN |
| Apr 17, 2002 | K020947 | MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS Smith & Nephew, Inc. | FRN |
| Mar 27, 2002 | K020881 | MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT Science Incorporated | FRN |
| Feb 15, 2002 | K020251 | PARAGON INFUSION SYSTEM I-Flow Corp. | FRN |
| Dec 31, 2001 | K014091 | STRYKER PAINPUMP Stryker Corp. | FRN |
| Dec 12, 2001 | K013767 | SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP Sterling Medivations, Inc. | FRN |
| Oct 2, 2001 | K012383 | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C Alaris Medical Systems, Inc. | FRN |
| Sep 19, 2001 | K011975 | HORIZON OUTLOOK WITH DOSECOM B.Braun Medical, Inc. | FRN |
| Aug 28, 2001 | K012044 | BI-PHASIC INFILTRATOR Reliance Medical Corp. | FRN |
| Jul 17, 2001 | K003966 | WUNDCATH CONDUCTION CATHETER Micor, Inc. | FRN |
| Jun 25, 2001 | K010937 | SEP-10S PLUS, AND SP-12S PRO. Viltechmeda, LT | FRN |
| Jun 5, 2001 | K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 Abbott Laboratories | FRN |
| Jun 5, 2001 | K003543 | STRYKER PAINPUMP PCA Stryker Instruments | FRN |
| May 15, 2001 | K010566 | COLLEAGUE VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp | FRN |
| May 1, 2001 | K011096 | ABBOTT ACCLAIM ENCORE, MODEL 12237 Abbott Laboratories | FRN |
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