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 30, 1984 | K841017 | PROVIDER INFUSION SET Pancretec, Inc. | FRN |
| Apr 13, 1984 | K833983 | PROVIDER U-100 INSULIN INFUSION SYS Pancretec, Inc. | FRN |
| Apr 5, 1984 | K841018 | PANCRETEC PUMP CHECK Pancretec, Inc. | FRN |
| Mar 30, 1984 | K840616 | MINI-PUMP U-100 Advanced Bio Systems, Inc. | FRN |
| Feb 28, 1984 | K832470 | INFUSION PUMP Delta Medical Industries | FRN |
| Feb 27, 1984 | K840263 | LIFECARE 4/HOMECARE - 4H PUMP Abbott Laboratories | FRN |
| Jan 30, 1984 | K834461 | INFUSION PUMP PRIMER Parker Hannifin Corp. | FRN |
| Jan 30, 1984 | K833723 | MODEL 2000 AMBULATORY MED. INFUSER Parker Hannifin Corp. | FRN |
| Dec 29, 1983 | K833958 | FLO-GARD 8100 INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Dec 29, 1983 | K833655 | GILLETTE SABRE SYRINGE Intermedics, Inc. | FRN |
| Dec 27, 1983 | K832285 | VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY Travenol Laboratories, S.A. | FRN |
| Nov 29, 1983 | K832606 | WINDSOR MEDICAL VARIOUS MODELS Windsor Medical, Inc. | FRN |
| Nov 28, 1983 | K833306 | BETATRON I AMBULATORY INSULIN PUMP Cardiac Pacemakers, Inc. | FRN |
| Nov 28, 1983 | K832350 | INTRABIONIC CO. - MICRO SYRINGE Intrabionic Co. | FRN |
| Nov 28, 1983 | K832349 | PROGRAMED Intrabionic Co. | FRN |
| Nov 3, 1983 | K832923 | AMBULATORY INSULIN INFUSION PUMP Caridac Pacemakers, Inc. | FRN |
| Nov 3, 1983 | K832755 | INFUSION PUMP & IV SETS #4000 Omni-Glow, Inc. | FRN |
| Oct 4, 1983 | K832641 | WINDSOR MEDICAL MODEL 52 Windsor Medical, Inc. | FRN |
| Sep 16, 1983 | K830657 | AMBULATORY MARK XI DRUG INFUSION DEV- Windsor Medical, Inc. | FRN |
| Sep 12, 1983 | K832410 | GRASEBY DYNAMICS MS302 SYRINGE DRIVER Intermedics, Inc. | FRN |
| Sep 12, 1983 | K832289 | LIFECARE MICRO PUMP Abbott Laboratories | FRN |
| Sep 12, 1983 | K831534 | PUMPETTE AS8P-INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Sep 12, 1983 | K831444 | SINGLE USE SYRINGE #103 PERSONAL MEDIC Pacesetter Systems | FRN |
| Sep 12, 1983 | K830389 | ACCU-RYNGE PUMP SP-250 Delta Medical Industries | FRN |
| Aug 16, 1983 | K832167 | CORPAK VTR 300 ENTERNAL PUMP Corpak Co. | FRN |
| Aug 16, 1983 | K832166 | FLO-GARD 8500 MICROINFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Aug 16, 1983 | K830656 | AMBULATORY MARK III INFUSION DEVICE Windsor Medical, Inc. | FRN |
| Aug 12, 1983 | K832120 | PROMINJET PUMP Abbott Laboratories | FRN |
| Aug 12, 1983 | K832008 | INFUTROL 7000 INFUSION PUMP Valleylab, Inc. | FRN |
| Aug 12, 1983 | K831897 | BETA I PROGRAMMABLE INFUSION PUMP Orange Medical Instruments, Inc. | FRN |
| Aug 12, 1983 | K831761 | SIMPLICITY PLUS Critikon Company, LLC | FRN |
| Aug 8, 1983 | K831935 | ENTERNAL PUMP & ADMIN. SET 430 Imed Corp. | FRN |
| Jun 30, 1983 | K831258 | FLO-GARD 6100 VOLUMETRIC INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Jun 15, 1983 | K830906 | PULSAMAT MODEL 1050 Ferring Laboratories, Inc. | FRN |
| Jun 3, 1983 | K831203 | Y-TYPE BACKCHECK MICROBORE EXTEN. SET Abbott Laboratories | FRN |
| May 9, 1983 | K831259 | RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE Cardiac Pacemakers, Inc. | FRN |
| Apr 14, 1983 | K830809 | GRASE BY DYNAMICS MS 27 SYRINGE DRIVER Intermedics, Inc. | FRN |
| Apr 14, 1983 | K830486 | INFUSION PUMP #AS*6H Baxter Healthcare Corp | FRN |
| Apr 14, 1983 | K830452 | PCA PUMP Abbott Laboratories | FRN |
| Apr 12, 1983 | K830936 | TREONIC IP5 Vickers America Medical Corp. | FRN |
| Mar 31, 1983 | K830605 | PUMP PALL AMBULATORY INSULIN INFUSION Biomedical Devices, Inc. | FRN |
| Mar 31, 1983 | K830544 | WINDSOR MEDICAL, INC. 50-01-028 Windsor Medical, Inc. | FRN |
| Mar 31, 1983 | K830490 | MODEL 50-01-27 Windsor Medical, Inc. | FRN |
| Mar 31, 1983 | K830454 | IMS MINIATURE VOLUMETRIC INFUSION PUMP Ziehm International, Inc. | FRN |
| Mar 24, 1983 | K830570 | PERSONAL MEDICATION INFUSER Pacesetter Systems | FRN |
| Mar 24, 1983 | K822842 | AMBULATORY MARK I Windsor Medical, Inc. | FRN |
| Mar 7, 1983 | K830423 | SYRINGE DRIVER MS-16 Intermedics, Inc. | FRN |
| Mar 1, 1983 | K830355 | SECURA IV VOLUMETRIC INFUSION PUMP Diatek, Inc. | FRN |
| Feb 28, 1983 | K830102 | HARVARD APPARATUS INTERMITTENT INFUSION C.R. Bard, Inc. | FRN |
| Feb 18, 1983 | K830151 | EXTERNAL INFUSION PUMP Intermedics, Inc. | FRN |
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