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 |
|---|---|---|---|
| Apr 6, 2001 | K010924 | MODIFICATION TO PLUM XL INFUSION PUMP Abbott Laboratories | FRN |
| Dec 13, 2000 | K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L Breg, Inc. | FRN |
| Dec 12, 2000 | K003616 | COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp | FRN |
| Dec 5, 2000 | K003582 | FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 Fluidsense Corp. | FRN |
| Dec 4, 2000 | K003029 | INFUSOMAT P B.Braun Medical, Inc. | FRN |
| Sep 18, 2000 | K002679 | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 Baxter Healthcare Corp | FRN |
| Sep 5, 2000 | K002380 | INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM Baxter Healthcare Corp | FRN |
| Aug 18, 2000 | K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 Minimed, Inc. | FRN |
| Aug 18, 2000 | K001828 | PARADIGM 1.5ML RESERVOIR, MODEL 326 Minimed, Inc. | FRN |
| Aug 1, 2000 | K993524 | ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS Alaris Medical Systems, Inc. | FRN |
| Jul 28, 2000 | K002211 | COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 Baxter Healthcare Corp | FRN |
| Jul 20, 2000 | K002126 | ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP Abbott Laboratories | FRN |
| Jun 21, 2000 | K001629 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM Disetronic Medical Systems AG | FRN |
| Jun 8, 2000 | K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM Sims Deltec, Inc. | FRN |
| May 31, 2000 | K994274 | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) Quest Medical, Inc. | FRN |
| May 9, 2000 | K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Mar 24, 2000 | K000821 | ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION Abbott Laboratories | FRN |
| Mar 8, 2000 | K994375 | HORIZON LIGHT B.Braun Medical, Inc. | FRN |
| Mar 3, 2000 | K994374 | SOAKER CATHETER I-Flow Corp. | FRN |
| Feb 22, 2000 | K994275 | SIMS PORTEX ANESTHESIA CATHETER Sims Portex, Inc. | FRN |
| Jan 18, 2000 | K991936 | 3.0 ML RESERVOIR, MODEL 103/193 Medtronic Minimed | FRN |
| Dec 22, 1999 | K994039 | ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB Abbott Laboratories | FRN |
| Nov 1, 1999 | K993387 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K Baxter Healthcare Corp | FRN |
| Oct 15, 1999 | K991203 | IRRIGATION OR INFUSION PUMP K PUMP Kmi Kolster Methods, Inc. | FRN |
| Sep 8, 1999 | K992044 | INFUSION DYNAMICS POWER INFUSER MODEL M100B Infusion Dynamics, Inc. | FRN |
| Aug 30, 1999 | K991437 | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 Wells Johnson Co. | FRN |
| Aug 24, 1999 | K992672 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. | FRN |
| Jul 1, 1999 | K991275 | WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS Mckinley, Inc. | FRN |
| Jun 23, 1999 | K991013 | MINIMED 407C INFUSION PUMP, MODEL 407C Medtronic Minimed | FRN |
| May 13, 1999 | K991501 | ACCLAIM INFUSION PUMP Abbott Laboratories | FRN |
| May 13, 1999 | K991363 | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU Sorenson Medical, Inc. | FRN |
| May 12, 1999 | K990447 | 1000 PRESSURE INFUSION SIGMACON 1000 Valley West, Inc. | FRN |
| Apr 23, 1999 | K990425 | SIDEKICK INFUSION KIT I-Flow Corp. | FRN |
| Apr 6, 1999 | K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Mar 25, 1999 | K990518 | PEREGRINE WET SET, MODEL PD400.00 Peregrine Surgical , Ltd. | FRN |
| Mar 19, 1999 | K990101 | PAIN CONTROL INFUSION PUMP Sgarlato Laboratories, Inc. | FRN |
| Feb 24, 1999 | K980751 | SABRATEK 4040 INFUSION PUMP Sabratek Corp. | FRN |
| Feb 12, 1999 | K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM Disetronic Medical Systems | FRN |
| Feb 4, 1999 | K983005 | PERFUSOR COMPACT B.Braun Medical, Inc. | FRN |
| Jan 12, 1999 | K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories | FRN |
| Dec 29, 1998 | K974332 | VARIABLE PRESSURE SYRINGE PUMP Alaris Medical Systems, Inc. | FRN |
| Dec 9, 1998 | K980378 | MELODIE INFUSION PUMP Compagnie DE Developpement Aguettant | FRN |
| Dec 4, 1998 | K981816 | CUE AMBULATORY VOLUMETRIC INFUSION PUMP Becton Dickinson Curlin, LLC | FRN |
| Nov 30, 1998 | K983975 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. | FRN |
| Nov 30, 1998 | K982170 | FLUIDSENSE FLUID DELIVERY SYSTEM Fluidsense Corp. | FRN |
| Nov 20, 1998 | K983838 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP Abbott Laboratories | FRN |
| Nov 4, 1998 | K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 Sims Deltec, Inc. | FRN |
| Nov 2, 1998 | K982836 | CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM Sims Deltec, Inc. | FRN |
| Oct 6, 1998 | K983321 | MICROFUSE DUAL RATE INFUSER Baxa Corp. | FRN |
| Sep 30, 1998 | K982020 | METRON QA-IDS I.V. PUMP TESTER Metron U.S., Inc. | FRN |
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