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 |
|---|---|---|---|
| Aug 17, 1989 | K883645 | LIFECARE MICRO PUMP Abbott Laboratories | FRN |
| Aug 3, 1989 | K890862 | AMBULATORY INFUSION PUMP Medfusion, Inc. | FRN |
| Jul 28, 1989 | K890786 | IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200 Valleylab, Inc. | FRN |
| Jul 27, 1989 | K890120 | SYRINGE INFUSION PUMP Medfusion, Inc. | FRN |
| Jul 25, 1989 | K892906 | 60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Jul 14, 1989 | K884505 | BASAL/BOLUS INFUSORS Baxter Healthcare Corp | FRN |
| Jun 9, 1989 | K891583 | IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES Y | FRN |
| May 16, 1989 | K890783 | GRIESHABER VISCOELASTIC INJECTION SYSTEM Grieshaber & Co. | FRN |
| Apr 19, 1989 | K890282 | RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP Abbott Laboratories | FRN |
| Apr 14, 1989 | K883609 | ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR Squibb Diagnostics | FRN |
| Mar 23, 1989 | K890062 | CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. | FRN |
| Mar 8, 1989 | K890457 | MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP Medtronic Minimed | FRN |
| Feb 28, 1989 | K883796 | LIFECARE MICRO PUMP Abbott Laboratories | FRN |
| Feb 28, 1989 | K882249 | M.I.P. - PUMP Intro-Med, Inc. | FRN |
| Feb 28, 1989 | K881759 | BT-1 INFUSION PUMP Ferring Laboratories, Inc. | FRN |
| Feb 27, 1989 | K885083 | INFUSA-PLATE(TM) EX Kalayjian Ent. | FRN |
| Dec 19, 1988 | K883993 | MODIFIED IMED GEMINI PC-1 INFUSION PUMP Imed Corp. | FRN |
| Dec 12, 1988 | K884014 | FLO-GARD VP Baxter Healthcare Corp | FRN |
| Nov 18, 1988 | K883577 | BARD INFUSOR PUMP C.R. Bard, Inc. | FRN |
| Nov 8, 1988 | K883587 | BIOSEARCH 3600 ENTRI FEEDING PUMP Biosearch Medical Products, Inc. | FRN |
| Nov 1, 1988 | K883653 | EP-100 INFUSION PUMP Stereotactic Medical Systems, Inc. | FRN |
| Nov 1, 1988 | K882598 | 250 ML BAG W/Y INJECT. & 12 EXTENSION SET Prn Services, Inc. | FRN |
| Oct 27, 1988 | K883902 | INFUSA-PLATE Kalajian Ent. | FRN |
| Oct 25, 1988 | K881079 | UVP VOLUMED 2001 Ferguson Medical | FRN |
| Oct 14, 1988 | K883003 | MULTI-DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
| Sep 20, 1988 | K882594 | THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM Omni-Flow, Inc. | FRN |
| Sep 15, 1988 | K882556 | BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI. Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Sep 1, 1988 | K880857 | SYRINGE PUMP MS2000 Smash Ent., Inc. | FRN |
| Aug 24, 1988 | K882159 | 522 INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. | FRN |
| Aug 12, 1988 | K882102 | PROVIDER ONE INFUSION SYSTEM Pancretec, Inc. | FRN |
| Aug 11, 1988 | K882107 | PERFUSOR SECURA SYRINGE PUMP Burron Medical, Inc. | FRN |
| Aug 11, 1988 | K882106 | PERFUSOR M SYRINGE PUMP Burron Medical, Inc. | FRN |
| Aug 11, 1988 | K882047 | ENTRUST(TM) MODEL 800 Avi, Inc. | FRN |
| Jun 20, 1988 | K880733 | BARD PCA II INFUSION PUMP C.R. Bard, Inc. | FRN |
| May 23, 1988 | K881590 | ADFUSE(TM) Healthtek, Inc. | FRN |
| May 20, 1988 | K875332 | IVAC VOLUMETRIC PUMP - MODEL 590 Y | FRN |
| May 11, 1988 | K875316 | BIONICA MDS 110 PCA Bionica, Inc. | FRN |
| May 11, 1988 | K874546 | SIM MODULE Critikon Company, LLC | FRN |
| Apr 29, 1988 | K875365 | MODEL 200A INFUSION PUMP Avi, Inc. | FRN |
| Apr 29, 1988 | K875348 | MODEL 400A INFUSION PUMP Avi, Inc. | FRN |
| Apr 29, 1988 | K875347 | MODEL 210A INFUSION PUMP Avi, Inc. | FRN |
| Apr 25, 1988 | K880479 | IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP Imed Corp. | FRN |
| Apr 25, 1988 | K880204 | CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. | FRN |
| Apr 21, 1988 | K880623 | MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP Medtronic Minimed | FRN |
| Apr 21, 1988 | K880569 | TEAMMATE(TM) Infusion Systems Corp. | FRN |
| Apr 19, 1988 | K880625 | HALF HOUR INFUSOR Baxter Healthcare Corp | FRN |
| Apr 13, 1988 | K875364 | MODIFIED PCA INFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Mar 29, 1988 | K875174 | RATEMINDER V INFUSION PUMP Critikon Company, LLC | FRN |
| Feb 22, 1988 | K874181 | BAXTER BEDSIDE SYSTEM Travenol Laboratories, S.A. | FRN |
| Feb 11, 1988 | K874564 | MINIMED III INFUSION PUMP & UNI-SET ADMIN SET Medtronic Minimed | FRN |
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