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 |
|---|---|---|---|
| Dec 29, 1986 | K864138 | MINIMED MODEL 404-S EXTERNAL INFUSION PUMP Medtronic Minimed | FRN |
| Dec 12, 1986 | K864517 | MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS Medtronic Minimed | FRN |
| Dec 12, 1986 | K863997 | ABBOTT LIFECARE(R) 4100 PCA INFUSER Abbott Laboratories | FRN |
| Nov 19, 1986 | K864106 | SR-MODEL 230 (MODIFICATION) Hirata Sangyo Co. USA, Inc. | FRN |
| Oct 7, 1986 | K863683 | BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP C.R. Bard, Inc. | FRN |
| Sep 23, 1986 | K862295 | MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER Imed Corp. | FRN |
| Sep 5, 1986 | K860353 | SYRINGE INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Aug 27, 1986 | K862927 | CADD-1, MODEL 5100 HF Deltec Systems, Inc. | FRN |
| Jul 31, 1986 | K861539 | NIKKISO INFUSION PUMP MODEL PFA-02 International Medical Products, Inc. | FRN |
| Jul 24, 1986 | K861598 | INTELLIGRAPH(TM) PROGRAMMER Intelligent Medicine, Inc. | FRN |
| Jun 30, 1986 | K861208 | INTELLIJECT MEDICATION SYRINGE Intelligent Medicine, Inc. | FRN |
| Jun 30, 1986 | K861207 | INTELLIJECT INFUSION PUMP Intelligent Medicine, Inc. | FRN |
| Jun 23, 1986 | K861209 | STREAM-SWITCH MANIFOLD Intelligent Medicine, Inc. | FRN |
| Jun 23, 1986 | K861040 | ENTERNAL INFUSER MULTIPUMP 203 Medix Medical Electronics (U.S.A.), Inc. | FRN |
| Jun 12, 1986 | K861001 | PARENTERAL INFUSER MEDIPUMP 204 Medix Medical Electronics (U.S.A.), Inc. | FRN |
| Jun 9, 1986 | K861436 | SOF SET, MODELS 111 AND 112 Pacesetter Systems | FRN |
| Jun 9, 1986 | K861324 | PATIENTCARE 1000 Criticare Technologies Corp. | FRN |
| Jun 9, 1986 | K860222 | 70 ML RESERVOIR BAG AND ADMINISTRATION SETS Prn Services, Inc. | FRN |
| May 27, 1986 | K860857 | SOF SET, MODELS 113 AND 114 Pacesetter Systems | FRN |
| May 20, 1986 | K861007 | BECTON DICKINSON PCAINFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| May 6, 1986 | K860969 | FLUID MANAGEMENT SYSTEM (MODIFIED) Haemonetics Corp. | FRN |
| Apr 22, 1986 | K860694 | IV7200 AND IV7400 INFUSION PUMP Valleylab, Inc. | FRN |
| Apr 18, 1986 | K860162 | FLO-GARD 6200 VOLUMETRIC INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Apr 9, 1986 | K860229 | MODEL 900 INFUSION PUMP C.R. Bard, Inc. | FRN |
| Apr 7, 1986 | K860218 | SYRINGE PUMP: VM 07 Vial Medical , Ltd., CA | FRN |
| Mar 24, 1986 | K860086 | ENTERAL NUTRITION PUMPS PN 1000 AND VM 05 Vial Medical , Ltd., CA | FRN |
| Mar 18, 1986 | K854318 | LIFEPORT AMBULATORY INFUSION PUMP Strato Medical Corp. | FRN |
| Mar 18, 1986 | K853664 | HEPARIN MICRO-INFUSOR Y | FRN |
| Mar 12, 1986 | K852168 | ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY Y | FRN |
| Mar 7, 1986 | K854964 | CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. Deltec Systems, Inc. | FRN |
| Feb 27, 1986 | K860502 | G.A.S./GRIESHABER AIR SYSTEM Grieshaber & Co. | FRN |
| Feb 27, 1986 | K855215 | AIR/FLUID EXCHANGE SYSTEM Mira, Inc. | FRN |
| Feb 19, 1986 | K860492 | NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE Nordisk Infuser System | FRN |
| Feb 13, 1986 | K854157 | PMT ACCUPRESSURE INFUSION SYSTEM 3601 Progress Mankind Technology | FRN |
| Jan 27, 1986 | K853629 | BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO C.R. Bard, Inc. | FRN |
| Jan 16, 1986 | K853814 | MP0400 ADULT, PERISTALIC INFUSION PUMP Medex, Inc. | FRN |
| Dec 10, 1985 | K854074 | MODEL 200 INFUSION PUMP Avi, Inc. | FRN |
| Dec 10, 1985 | K854073 | MODEL 210 INFUSION PUMP Avi, Inc. | FRN |
| Dec 9, 1985 | K852645 | FLUID MANAGEMENT SYSTEM Haemonetics Corp. | FRN |
| Dec 2, 1985 | K853881 | THE TRAVENOL 5 ML/HR INFUSOR Travenol Laboratories, S.A. | FRN |
| Nov 18, 1985 | K853393 | INSULIN PUMP INSUMAT 229 Medix Medical Electronics (U.S.A.), Inc. | FRN |
| Nov 13, 1985 | K850792 | ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP Janssen Pharmaceutica, Inc. | FRN |
| Nov 12, 1985 | K853584 | CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP Deltec Systems, Inc. | FRN |
| Nov 6, 1985 | K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 Erika, Inc. | FRN |
| Nov 1, 1985 | K842905 | TRAVENOL MULTIDAY INFUSOR 2C1080 Travenol Laboratories, S.A. | FRN |
| Aug 21, 1985 | K852965 | ENTERAL FEEDING PUMP Empire Industries, Inc. | FRN |
| Jul 5, 1985 | K852358 | SYRINGE INFUSION PUMP - AS 20 SERIES Baxter Healthcare Corp | FRN |
| Jul 5, 1985 | K851821 | VI-FLOW PUMP WITH VI-SET Vital Canada, Inc., CA | FRN |
| Jun 7, 1985 | K852073 | VIAL SYRINGE PUMPS, SE200, SE200B & SE400 Hospal Medical Corp. | FRN |
| Jun 7, 1985 | K852060 | INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 Cardiac Pacemakers, Inc. | FRN |
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