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 |
|---|---|---|---|
| Feb 7, 1983 | K830177 | HARVARD APPARATUS FAMILY OF FLUID INFUS C.R. Bard, Inc. | FRN |
| Jan 26, 1983 | K830038 | SIGMA 7000-6000 INFUSION PUMPS Sigma | FRN |
| Jan 26, 1983 | K830017 | VOLUMETRIC PUMP ADMIN. SETS Travenol Laboratories, S.A. | FRN |
| Jan 26, 1983 | K820038 | SIGMA 7000 Sigma | FRN |
| Dec 22, 1982 | K823406 | GUARDIAN 110, VOL. CONTROL DELIV. SYS Avi, Inc. | FRN |
| Nov 30, 1982 | K823204 | BETATRON II Cardiac Pacemakers, Inc. | FRN |
| Nov 30, 1982 | K823193 | AMBULATORY INSULIN INFUSION PUMP 9205 Cpi, Inc. | FRN |
| Nov 30, 1982 | K823063 | FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB Travenol Laboratories, S.A. | FRN |
| Nov 24, 1982 | K823035 | COMPUTER INTERFACE MODULE CIM Y | FRN |
| Nov 3, 1982 | K822989 | HARVARD APPARATUS SINGLE SPEED SYRINGE C.R. Bard, Inc. | FRN |
| Oct 18, 1982 | K822454 | SYRINGE PUMP 209-100 Medix Corp. | FRN |
| Oct 8, 1982 | K822571 | SYRINGE PUMP Hirata Sangyo Co. USA, Inc. | FRN |
| Sep 30, 1982 | K822761 | DELIVERY TUBE SET #2226 Delta Medical Industries | FRN |
| Jun 22, 1982 | K821661 | FLEXIFLO-II Abbott Laboratories | FRN |
| Jun 10, 1982 | K821069 | MODEL AS6M INFUSION PUMP Baxter Healthcare Corp | FRN |
| May 5, 1982 | K821148 | ETHOX FOOD PUMP STAND W/POLE CLAMP Ethox Corp. | FRN |
| May 3, 1982 | K821047 | IVAC 630 & VOLUMETRIC INFUSION PUMP Y | FRN |
| Apr 29, 1982 | K820946 | AS 70 VOLUMETRIC INFUSION PUMP Narco Scientific | FRN |
| Apr 21, 1982 | K820860 | VOLUMETRIC PUMP CASSETTE W/ATTACHED SET Travenol Laboratories, S.A. | FRN |
| Apr 15, 1982 | K820764 | IVAC MODEL 160 AIR-IN-LINE SENSOR Y | FRN |
| Apr 14, 1982 | K820726 | ACCUSET (R) CASSETTE Imed Ireland, Ltd. | FRN |
| Mar 26, 1982 | K820482 | ACCU-RYNGE INSULIN PUMP #SP-250 Delta Medical Industries | FRN |
| Feb 18, 1982 | K813644 | MODEL 2650 HIGH CAPACITY DUAL SYRINGE Harvard Apparatus, Inc. | FRN |
| Feb 10, 1982 | K820219 | OPEN LOOP INFUSION PUMP Iatric Devices | FRN |
| Feb 10, 1982 | K820063 | KEOFEED 500 ENTERIC FEEDING PUMP Hedeco | FRN |
| Feb 1, 1982 | K813562 | SYRINGE DRIVER 209 Medix Medical Electronics (U.S.A.), Inc. | FRN |
| Jan 28, 1982 | K813590 | MODEL AS6B INFUSION PUMP Baxter Healthcare Corp | FRN |
| Jan 25, 1982 | K820073 | OPEN LOOP AMBULATORY INSULIN INFUSION Cardiac Pacemakers, Inc. | FRN |
| Jan 22, 1982 | K813473 | 5B SLAVE MODULE SYRINGE PUMP Baxter Healthcare Corp | FRN |
| Jan 5, 1982 | K813455 | PUMP & DETECTOR Medlog GmbH Marketing Services | FRN |
| Dec 31, 1981 | K813403 | FLO-GARD 8000 INFUSION PUMP SYSTEM Travenol Laboratories, S.A. | FRN |
| Dec 2, 1981 | K812898 | PE-01 ELECTRONIC INFUSION PUMP Egnell, Inc. | FRN |
| Nov 6, 1981 | K812917 | PORTABLE LIDOCAINE INFUSION PUMP Cardiac Pacemakers, Inc. | FRN |
| Nov 6, 1981 | K810850 | PERSONAL MEDICATION INFUSER Pacesetter Systems | FRN |
| Oct 27, 1981 | K812824 | PRESSURE DISC COMPONENT FOR ACCUSET Imed Corp. | FRN |
| Oct 27, 1981 | K812823 | IMED MODEL 970 & 975 VOL. INFUSION PUMP Imed Corp. | FRN |
| Sep 16, 1981 | K812499 | INFUSION PUMP Nu Tech Medical Systems | FRN |
| Sep 16, 1981 | K812442 | 3M INFUSION SYSTEM 3M Company | FRN |
| Sep 11, 1981 | K811783 | ENDOPUMP Medtron Development , Ltd. | FRN |
| Sep 9, 1981 | K812339 | TERUFUSION INFUSION PUMP MODEL STC-502 Terumo Medical Corp. | FRN |
| Jul 31, 1981 | K812042 | INFUSION PUMP MODEL 200/201 Medix Medical Electronics (U.S.A.), Inc. | FRN |
| Jul 31, 1981 | K812021 | VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Jul 28, 1981 | K812035 | IMED ACCUSET CASSETTE Imed Corp. | FRN |
| Jul 23, 1981 | K811917 | I.V. ADMIN. SETS FOR THE AMP MARK IV PMP American Medical Products, Inc. | FRN |
| Jul 20, 1981 | K811933 | GUARDIAN, VOLUMETRIC CONTROL DELIVERY Avi, Inc. | FRN |
| Jul 20, 1981 | K811918 | AMP MARK IV INFUSION PUMP American Medical Products, Inc. | FRN |
| Jul 20, 1981 | K811884 | IVAC 700 SYRINGE INFUSION PUMP Y | FRN |
| Jul 10, 1981 | K811774 | OPEN LOOP AMBULATORY INFUSION DEVICE Cardiac Pacemakers, Inc. | FRN |
| Jul 10, 1981 | K811739 | ENTRI ENTERAL FEEDING PUMP Biosearch Medical Products, Inc. | FRN |
| Jul 10, 1981 | K811272 | RAZEL MODEL C Razel Scientific Instruments, Inc. | FRN |
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