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 30, 1985 | K851564 | MODEL 2000 INDULIN INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| May 30, 1985 | K851351 | ENTERAL FEEDING PUMP Empire Industries, Inc. | FRN |
| May 13, 1985 | K850997 | UVP 2000 VOLUMED -TENTATIVE Sterling Medical Devices, Inc. | FRN |
| May 8, 1985 | K851447 | IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP Y | FRN |
| May 8, 1985 | K851360 | IMED GRAVISET INTRAVASCULAR ADMIN. SET Imed Corp. | FRN |
| May 7, 1985 | K851017 | QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU Quest Medical, Inc. | FRN |
| Apr 9, 1985 | K850729 | ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 Surgidev Corp. | FRN |
| Apr 9, 1985 | K850674 | CORMED II AMBULATORY INFUSION PUMP Cormed, Inc., Sub. C.R.Bard, Inc. | FRN |
| Apr 9, 1985 | K850669 | PROMINJECT PROGRAMMABLE INFUSION PUMP Pharmacia, Inc. | FRN |
| Apr 9, 1985 | K850653 | IMED 440 INFUSION PUMP & ADMINISTRATION SET Imed Corp. | FRN |
| Mar 21, 1985 | K850488 | STRATOFUSE SYRINGE PIGGYBACK PUMP 1030 Strato Medical Corp. | FRN |
| Mar 13, 1985 | K850183 | CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M Deltec Systems, Inc. | FRN |
| Mar 13, 1985 | K843311 | IV ADMIN. SET FOR MVP 1 INFUSION PUMP Ziehm International, Inc. | FRN |
| Mar 12, 1985 | K844401 | REPRO-MED SYSTEMS INFUSION DEVICE Repro-Med Systems, Inc. | FRN |
| Mar 6, 1985 | K844915 | IMED 980 VOLUMETRIC INFUSION PUMP Imed Corp. | FRN |
| Feb 22, 1985 | K850098 | SILVER SPOON ENTERAL FEEDING PUMP Sterling Medical Devices, Inc. | FRN |
| Feb 15, 1985 | K841374 | HOME PRO VOLUMETRIC INFUSION PUMP American Edwards Laboratories | FRN |
| Jan 28, 1985 | K844730 | BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE C.R. Bard, Inc. | FRN |
| Jan 28, 1985 | K844719 | 360 INFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jan 28, 1985 | K844718 | MODEL 1001 A0kfusion Systems, Inc. | FRN |
| Jan 28, 1985 | K844627 | STRATOFUSE SYRINGE PIGGYBACK PUMP Strato Medical Corp. | FRN |
| Jan 25, 1985 | K844768 | ABBOTT LIFECARE 500 INFUSER Abbott Laboratories | FRN |
| Jan 25, 1985 | K844091 | ABBOTT LIFECARE 900 VOLUMETRIC PUMP Abbott Laboratories | FRN |
| Jan 22, 1985 | K844851 | MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 Pacesetter Systems | FRN |
| Jan 22, 1985 | K844792 | MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A Pacesetter Systems | FRN |
| Dec 18, 1984 | K844078 | PROVIDER PA 3000 INFUSION SYSTEM Pancretec, Inc. | FRN |
| Dec 6, 1984 | K843878 | HEPARIN INFUSIN PUMP Armament Systems, Inc. | FRN |
| Dec 6, 1984 | K843773 | CADD-PAC 5200 AMBULATORY INFUSION PUMP Deltec Systems, Inc. | FRN |
| Dec 6, 1984 | K843772 | CADD-1 5100 AMBULATORY INFUSION PUMP Deltec Systems, Inc. | FRN |
| Nov 30, 1984 | K843949 | I.V. PUMP ADMINISTRATION SET Travenol Laboratories, S.A. | FRN |
| Nov 15, 1984 | K843331 | INTERMEDICS/GRASEBY DYNAMICS MS 36 Intermedics, Inc. | FRN |
| Nov 2, 1984 | K842479 | I.V. TEAMATE Medical Delivery Systems | FRN |
| Oct 31, 1984 | K843616 | AVI GUARDIAN 400 INFUSION PUMP Avi, Inc. | FRN |
| Oct 31, 1984 | K843615 | AVI GUARDIAN MICRO 410 INFUSION PUMP Avi, Inc. | FRN |
| Oct 31, 1984 | K843548 | INTERMEDICS SYRINGE PUMP 710-02 Intermedics, Inc. | FRN |
| Oct 24, 1984 | K843168 | ENTERAL FEEDING PUMP 14-800 SERIES Biosearch Medical Products, Inc. | FRN |
| Oct 19, 1984 | K843274 | MODULAR VOLUMETRIC INFUSION PUMP SYS American Edwards Laboratories | FRN |
| Oct 19, 1984 | K842568 | RADIONUCLIDE INFUSION SYSTEM Squibb Diagnostics | FRN |
| Aug 17, 1984 | K842421 | ARGYLE ENTERITE ENTERAL FEEDING PUMP Sherwood Medical Co. | FRN |
| Jul 27, 1984 | K841827 | ENTEROPORT NUTRITION PUMP Diatek, Inc. | FRN |
| Jul 25, 1984 | K842289 | SR- MODEL 230 Hirata Sangyo Co. USA, Inc. | FRN |
| Jul 25, 1984 | K842263 | MTP E.V. INFUSION PUMP Ziehm International, Inc. | FRN |
| Jul 18, 1984 | K842027 | IVAC 3080 ENTERAL FEEDING PUMP Y | FRN |
| Jul 13, 1984 | K841922 | ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 American Edwards Laboratories | FRN |
| Jun 7, 1984 | K841784 | FLEXIFLO-III PORTABLE ENTERAL NUTRI Abbott Laboratories | FRN |
| Jun 7, 1984 | K841630 | ENTERAL NUTRITION PUMP Superior Plastic Products Corp. | FRN |
| Jun 1, 1984 | K841729 | ACCUPRO ENTERAL FEEDING PUMP American Mcgaw | FRN |
| May 21, 1984 | K841512 | ETHOX RELIA-FLO 2001 ENTERAL FEED Ethox Corp. | FRN |
| May 21, 1984 | K841481 | WINDSOR MEDICAL MODEL 50-00002 Windsor Medical, Inc. | FRN |
| May 14, 1984 | K841373 | PROVIDER IV MODEL 2000 INFUSIN SYS Pancretec, Inc. | FRN |
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