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 |
|---|---|---|---|
| May 13, 1993 | K923875 | SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS I-Flow Corp. | FRN |
| Apr 29, 1993 | K925449 | REPLACEMENT RECHARGEABLE BATTERY PACK'S Portable Power Systems, Inc. | FRN |
| Apr 20, 1993 | K923068 | AVI MODEL 3100 INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 7, 1993 | K923829 | LIFECARE 175 INFUSER -- MODIFICATION Abbott Laboratories | FRN |
| Jan 22, 1993 | K922074 | DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK Danby Medical , Ltd., GB | FRN |
| Jan 15, 1993 | K923981 | IVAC SYRINGE PUMP - 740 SERIES Y | FRN |
| Dec 23, 1992 | K923601 | PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON Abbott Laboratories | FRN |
| Sep 23, 1992 | K922909 | MEDICAL BATTERY PACKS Access / God Loves You | FRN |
| Sep 3, 1992 | K914122 | VITAL INFUSION PUMP Vital Resources Corp. | FRN |
| Sep 2, 1992 | K915407 | PHARMETRIX MEDIPUMP MODEL 524 Pharmetrix, Inc. | FRN |
| Aug 7, 1992 | K915566 | DISETRONIC PANOMAT PUMP Disetronic Medical Systems | FRN |
| Jun 15, 1992 | K915646 | VIVUS 50 AND VIVUS 100 PERSONAL INFUSER I-Flow Corp. | FRN |
| Jun 9, 1992 | K921378 | IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE Imed Corp. | FRN |
| May 26, 1992 | K921073 | AVI MODEL 480CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| May 26, 1992 | K921072 | AVI MODEL 470CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| May 18, 1992 | K914589 | SABRATEK 3030 INFUSION PUMP Sabratek Corp. | FRN |
| May 13, 1992 | K920013 | UNI-DOSE SYRINGE PUMP Electrochemical Drug Delivery, Inc. | FRN |
| May 8, 1992 | K920773 | DURAFUSE INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Apr 6, 1992 | K920681 | AVI MODEL 285CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K920680 | AVI MODEL 275CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K920588 | AVI MODEL 3000 INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K914988 | 500 INFUSER Excel Medical, Inc. | FRN |
| Mar 27, 1992 | K913891 | DISETRONIC(R) INFUSOR Disetronic Medical Systems | FRN |
| Mar 6, 1992 | K915499 | FLO-GARD 8000 HALF-SET Baxter Healthcare Corp | FRN |
| Mar 4, 1992 | K913931 | PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF Abbott Laboratories | FRN |
| Feb 28, 1992 | K915523 | FLO-GARD(R) 6301 Baxter Healthcare Corp | FRN |
| Feb 28, 1992 | K915522 | FLO-GARD(R) 6201 Baxter Healthcare Corp | FRN |
| Feb 14, 1992 | K912193 | 3000 INFUSION PUMP Graseby Medical , Ltd., GB | FRN |
| Feb 14, 1992 | K912192 | 3100 INFUSION PUMP Graseby Medical , Ltd., GB | FRN |
| Jan 24, 1992 | K914855 | MULTIPLE DOSE CONTROLLER Block Medical, Inc. | FRN |
| Jan 24, 1992 | K914854 | THUMPER Block Medical, Inc. | FRN |
| Jan 22, 1992 | K915231 | EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS Q-Life Systems, Inc., CA | FRN |
| Dec 19, 1991 | K914349 | PROVIDER APM INFUSION PUMP Abbott Laboratories | FRN |
| Dec 18, 1991 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP Mcgaw, Inc. | FRN |
| Dec 13, 1991 | K913907 | VIVUS PS (PROGRAMMING SOFTWARE) I-Flow Corp. | FRN |
| Nov 22, 1991 | K911782 | PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM Strato Medical Corp. | FRN |
| Nov 8, 1991 | K911103 | DANBY D.S.P. SYRINGE PUMP Isys Medical , Ltd., GB | FRN |
| Nov 5, 1991 | K904619 | INFU.DISK Electrochemical Drug Delivery, Inc. | FRN |
| Oct 30, 1991 | K914034 | INFUCARE SYRINGE PUMP TUBING SET Infucare Products, Inc. | FRN |
| Oct 30, 1991 | K913720 | PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED Abbott Laboratories | FRN |
| Oct 30, 1991 | K913719 | PANCRETEC I.V. MODEL 5500 INFUSER Abbott Laboratories | FRN |
| Oct 30, 1991 | K913718 | PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED Abbott Laboratories | FRN |
| Oct 21, 1991 | K913895 | FLO-GARD(R) 6200, 6300 & 8000 Baxter Healthcare Corp | FRN |
| Oct 17, 1991 | K912590 | AVI MODEL 400D INFUSION PUMP 3M Avi, Inc. | FRN |
| Oct 17, 1991 | K912589 | AVI MODEL 840D DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 10, 1991 | K904924 | INFUSA PU SYRINGE INFUSION PUMP Ferguson Medical | FRN |
| Sep 6, 1991 | K913056 | VOLUMETRIC INFUSION PUMP, MODIFICATION Mcgaw, Inc. | FRN |
| Sep 6, 1991 | K912591 | AVI MICRO 210D INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 6, 1991 | K904923 | INFUSA T SYRINGE INFUSION PUMP Ferguson Medical | FRN |
| Sep 4, 1991 | K904925 | INFUSA TS SYRINGE INFUSION PUMP Ferguson Medical | FRN |
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