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 |
|---|---|---|---|
| Sep 5, 1990 | K903783 | AVI MICRO 275CM INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 5, 1990 | K903782 | AVI MODEL 270CM INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 4, 1990 | K903788 | AVI MICRO 285CM INFUSION PUMP 3M Avi, Inc. | FRN |
| Aug 30, 1990 | K903789 | AVI MICRO 885 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. | FRN |
| Aug 30, 1990 | K903784 | AVI MODEL 480CM INFUSION PUMP 3M Avi, Inc. | FRN |
| Aug 30, 1990 | K903781 | AVI MODEL 880 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. | FRN |
| Aug 29, 1990 | K901755 | MODEL 3001 SYRINGE INFUSION PUMP Medfusion, Inc. | FRN |
| Aug 27, 1990 | K900468 | LIFECARE(R) MODEL 3 PUMP Abbott Laboratories | FRN |
| Aug 27, 1990 | K900467 | LIFECARE MODEL 4 PUMP Abbott Laboratories | FRN |
| Aug 21, 1990 | K901065 | INFUSION PUMP Kendall Mcgaw Laboratories, Inc. | FRN |
| Aug 21, 1990 | K896075 | CADD-PCA AMBULATORY INFUSION PUMPS Pharmacia Deltec, Inc. | FRN |
| Aug 17, 1990 | K902309 | PARKER MICROPUMP MODEL 2100 Chathamborough Research Group, Inc. | FRN |
| Aug 10, 1990 | K902835 | FTS-100 FLUID TRANSFER SYSTEM Richard James, Inc. | FRN |
| Aug 8, 1990 | K895644 | CADD-PCA AMBULATORY INFUSION PUMPS Pharmacia Deltec, Inc. | FRN |
| Aug 6, 1990 | K894506 | ENTERA-FLO ENTERAL FEEDING PUMP Delmed, Inc. | FRN |
| Aug 2, 1990 | K900375 | BECTON DICKINSON PROGRAM 2 INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Aug 2, 1990 | K896717 | PARTNER INFUSION SYSTEM: Q-Life Systems, Inc., CA | FRN |
| Jul 26, 1990 | K902092 | RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY Critikon Company, LLC | FRN |
| Jul 19, 1990 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jul 16, 1990 | K895710 | ABBOTT LIFECARE 4100 PCA INFUSER Abbott Laboratories | FRN |
| Jul 12, 1990 | K895709 | ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP Abbott Laboratories | FRN |
| Jul 11, 1990 | K900742 | RATE INFUSER PLUS Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jul 9, 1990 | K890736 | TFV-2300 INFUSION PUMP Nihon Kohden America, Inc. | FRN |
| Jun 26, 1990 | K895867 | PANCRETEC I.V. MODEL 5000 INFUSER Abbott Laboratories | FRN |
| Jun 26, 1990 | K893769 | LIFECARE MICRO PUMP (INFUSION PUMP) Abbott Laboratories | FRN |
| May 24, 1990 | K895436 | MODIFIED MINIMED III INFUSION PUMP Medtronic Minimed | FRN |
| May 15, 1990 | K900888 | LOCKBOX Pharmacia Deltec, Inc. | FRN |
| May 9, 1990 | K896422 | BURRON AMBULATORY DRUG DELIVERY SYSTEM Burron Medical, Inc. | FRN |
| May 2, 1990 | K896544 | MD2 PERSONAL INFUSION SYSTEM Norfolk Medical Products, Inc. | FRN |
| Apr 10, 1990 | K900699 | FLO-GARD 6300 BLOOD PUMPING INDICATION Baxter Healthcare Corp | FRN |
| Apr 3, 1990 | K900204 | AVI MODEL 840 DUAL CHANNEL INFUSION PUMP 3M Company | FRN |
| Mar 27, 1990 | K900057 | LIFECARE(R) 175 INFUSER Abbott Laboratories | FRN |
| Mar 15, 1990 | K897096 | MODEL 404A I.V. INFUSION PUMP ANALYZER Dynatech/Nevada, Inc. | FRN |
| Mar 8, 1990 | K897013 | AVI MICRO 210CM INFUSION PUMP 3M Company | FRN |
| Feb 6, 1990 | K896546 | HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) Block Medical, Inc. | FRN |
| Feb 2, 1990 | K891289 | FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP Baxter Healthcare Corp | FRN |
| Jan 4, 1990 | K896023 | OHMEDA 9000 SYRINGE PUMP Ohmeda Medical | FRN |
| Jan 2, 1990 | K895797 | IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE Imed Corp. | FRN |
| Dec 27, 1989 | K896593 | BECTON DICKINSON RATE INFUSER II SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Dec 27, 1989 | K895426 | AMBULATORY INFUSION PUMP Bionica, Inc. | FRN |
| Dec 22, 1989 | K894028 | AMBULATORY INFUSION SYSTEM AND ACCESSORIES Patient Solutions, Inc. | FRN |
| Dec 6, 1989 | K891237 | MODEL 600 SYRINGE PUMP 3M Company | FRN |
| Nov 2, 1989 | K894292 | BARD LIBERATOR DISPOSABLE INFUSION SYSTEM C.R. Bard, Inc. | FRN |
| Oct 31, 1989 | K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE Ortho Pharmaceutical Corp. | FRN |
| Oct 5, 1989 | K894321 | MODEL 285 INFUSION PUMP 3M Company | FRN |
| Oct 4, 1989 | K894360 | MODEL 280 INFUSION PUMP 3M Company | FRN |
| Oct 4, 1989 | K894320 | MODEL 480 INFUSION PUMP 3M Company | FRN |
| Aug 28, 1989 | K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK Ziehm International, Inc. | FRN |
| Aug 28, 1989 | K894037 | IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599 Y | FRN |
| Aug 28, 1989 | K892210 | MULTI-DRUG(TM) INFUSION SYSTEM I-Flow Corp. | FRN |
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