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 19, 1988 | K874649 | CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. | FRN |
| Jan 6, 1988 | K873884 | IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP Y | FRN |
| Jan 6, 1988 | K873746 | AUTO SYRINGE MODEL AS20G INFUSION PUMP Baxter Healthcare Corp | FRN |
| Jan 6, 1988 | K871881 | MODEL 3000 INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jan 5, 1988 | K872774 | BETATRON IV SYSTEM Cardiac Pacemakers, Inc. | FRN |
| Dec 30, 1987 | K873495 | PUMP TUBING SET Marquette Medical, Inc. | FRN |
| Dec 30, 1987 | K873494 | RESERVOIR BAG Marquette Medical, Inc. | FRN |
| Dec 29, 1987 | K873961 | INFUMED 300 AMBULATORY INFUSION PUMP Med Fusion Systems, Inc. | FRN |
| Dec 29, 1987 | K873522 | BARD AMBULATORY PCA DRUG DELIVERY SYSTEM C.R. Bard, Inc. | FRN |
| Dec 16, 1987 | K872516 | INFUSION PUMP MODEL 275 Avi, Inc. | FRN |
| Dec 16, 1987 | K872515 | INFUSION PUMP MODEL 470 Avi, Inc. | FRN |
| Dec 16, 1987 | K872514 | INFUSION PUMP MODEL 270 Avi, Inc. | FRN |
| Dec 16, 1987 | K871807 | BARD MICROINFUSER I INSULIN INFUSION PUMP C.R. Bard, Inc. | FRN |
| Dec 11, 1987 | K873938 | IVAC(R) DUAL RATE SET - MODEL C50066 Y | FRN |
| Dec 7, 1987 | K873847 | CORMED III AMBULATORY INFUSION PUMP C.R. Bard, Inc. | FRN |
| Dec 3, 1987 | K873776 | IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+ Y | FRN |
| Nov 24, 1987 | K873875 | BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc. | FRN |
| Nov 5, 1987 | K873161 | VALLEYLAB MODEL IV7200 INFUSION PUMP Valleylab, Inc. | FRN |
| Nov 3, 1987 | K872764 | IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053 Y | FRN |
| Nov 2, 1987 | K873444 | ENTECH ENTERAL PUMP AND SET Entech, Inc. | FRN |
| Oct 22, 1987 | K871806 | PROVIDER IV. MODEL 5000 INFUSION DEVICE Pancretec, Inc. | FRN |
| Oct 20, 1987 | K872952 | ULTRASONIC AIR-IN-LINE DETECTOR (AILD) Imed Corp. | FRN |
| Oct 20, 1987 | K872741 | NUTRIPUMP I M, Inc. | FRN |
| Oct 20, 1987 | K870656 | IMED(R) 980C VOLUMETRIC INFUSION PUMP Imed Corp. | FRN |
| Sep 4, 1987 | K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD Travenol Laboratories, S.A. | FRN |
| Aug 14, 1987 | K872850 | RATE INFUSER SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jul 27, 1987 | K872821 | INFUSION PUMP ENCLOSURE Pharmacia Deltec, Inc. | FRN |
| Jul 27, 1987 | K871728 | MODIFIED LIFECARE(R) 4100 PCA INFUSER Abbott Laboratories | FRN |
| Jul 16, 1987 | K871084 | NITROGLYCERINE PUMP SET Churchill Corp. | FRN |
| Jun 15, 1987 | K870330 | SP55 SYRINGE PUMP Vickers , Ltd., GB | FRN |
| Jun 4, 1987 | K870992 | IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP Imed Corp. | FRN |
| Jun 4, 1987 | K870991 | IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP Imed Corp. | FRN |
| May 6, 1987 | K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR Med Fusion Systems, Inc. | FRN |
| Apr 17, 1987 | K870444 | HOMEPRO II VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Mar 25, 1987 | K870279 | VP2000 INFUSION PUMP Vickers , Ltd., GB | FRN |
| Mar 17, 1987 | K864276 | PERSONAL INFUSION PUMP Bionica, Inc., AU | FRN |
| Mar 13, 1987 | K870768 | AC ADAPTER ACCESSORY, PRODUCT CODE 600123A Deltec Systems, Inc. | FRN |
| Mar 13, 1987 | K870242 | INTERMATE(TM) Infusion Systems Corp. | FRN |
| Feb 27, 1987 | K864997 | MEDTRAC VP VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Feb 10, 1987 | K865051 | GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP Panamedix, Inc. | FRN |
| Feb 10, 1987 | K864809 | IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580 Y | FRN |
| Feb 6, 1987 | K865060 | I.V. SET WITH DUAL-CHANNEL CASSETTE Abbott Laboratories | FRN |
| Feb 6, 1987 | K865059 | I.V. SET W/SINGLE-CHANNEL CASSETTE Abbott Laboratories | FRN |
| Feb 6, 1987 | K865058 | ABBOTT LIFECARE (R) 5000, PUMP SYSTEM Abbott Laboratories | FRN |
| Feb 4, 1987 | K863864 | AMBULATORY INFUSION PUMP, MODEL AS30C Travenol Laboratories, S.A. | FRN |
| Jan 21, 1987 | K864808 | STRATO(R) PCA INFUSER Strato Medical Corp. | FRN |
| Jan 16, 1987 | K864227 | PERCUPUMP (TM) E-Z-Em, Inc. | FRN |
| Jan 14, 1987 | K863532 | MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER Parker Hannifin Corp. | FRN |
| Jan 12, 1987 | K864233 | BARD HARVARD MINI-INFUSER 950 PUMP C.R. Bard, Inc. | FRN |
| Jan 5, 1987 | K863470 | DALTEX IV INFUSION PUMP Daltex Medical Sciences, Inc. | FRN |
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