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 25, 1998 | K973593 | BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 Bridge Medical, Inc. | FRN |
| Aug 3, 1998 | K981776 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X Alexander Mfg. Co. | FRN |
| Jun 16, 1998 | K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION Byron Medical | FRN |
| Mar 24, 1998 | K980089 | 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 Valley West, Inc. | FRN |
| Mar 17, 1998 | K974778 | ABBOTT GEMSTAR IV INFUSION PUMP Abbott Laboratories | FRN |
| Mar 9, 1998 | K980092 | SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS Smith & Nephew, Inc. | FRN |
| Jan 9, 1998 | K973917 | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM Sims Deltec, Inc. | FRN |
| Jan 5, 1998 | K973851 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 Alexander Mfg. Co. | FRN |
| Dec 18, 1997 | K973609 | IDA-4 AND IPT-MC Bio-Tek Instruments, Inc. | FRN |
| Nov 13, 1997 | K972284 | FLUID MANAGEMENT SYSTEM Belmont Instrument Corp. | FRN |
| Oct 7, 1997 | K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS Mcgaw, Inc. | FRN |
| Sep 12, 1997 | K973133 | BIG BAG 3000 PRESSURE INFUSOR Byron Medical | FRN |
| Jul 18, 1997 | K963574 | PULSE*SPRAY INJECTOR AngioDynamics, Inc. | FRN |
| Jul 3, 1997 | K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP Abbott Mfg., Inc. | FRN |
| Feb 26, 1997 | K961862 | MODELS IDA-2 PLUS AND IPT-1 Bio-Tek Instruments, Inc. | FRN |
| Jan 30, 1997 | K961975 | DISETRONIC D-MODEM Disetronic Medical Systems | FRN |
| Nov 21, 1996 | K960512 | GEMINI PC-ITX Imed Corp. | FRN |
| Oct 7, 1996 | K962709 | SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ Sigma Intl. | FRN |
| Aug 23, 1996 | K961263 | MODEL 1200 ABMULATORY INFUSION PUMP Patient Solutions, Inc. | FRN |
| Aug 23, 1996 | K960826 | CADD-PRIZM MODEL 6100 PUMP Sims Deltec, Inc. | FRN |
| Jul 18, 1996 | K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Jul 8, 1996 | K961703 | COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) Baxter Healthcare Corp | FRN |
| Jun 4, 1996 | K960957 | EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK Sims Deltec, Inc. | FRN |
| Jun 3, 1996 | K955258 | 3030 INFUSION PUMP Sabratek Corp. | FRN |
| May 24, 1996 | K954826 | DISETRONIC MULTIFUSE PUMP SYSTEM Disetronic Medical Systems | FRN |
| May 23, 1996 | K955180 | CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP Sims Deltec, Inc. | FRN |
| Mar 20, 1996 | K953896 | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS Imed Corp. | FRN |
| Feb 9, 1996 | K952967 | UNIMED MEDICAL DISPENSING PUMP A.Z.E. Medical, Inc. | FRN |
| Jan 18, 1996 | K952799 | ABBOTT XL3M INFUSION PUMP Abbott Laboratories | FRN |
| Dec 22, 1995 | K953098 | VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp | FRN |
| Dec 13, 1995 | K953731 | PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) Abbott Laboratories | FRN |
| Nov 15, 1995 | K944352 | SMARTDOSE III INFUSION CONTAINER River Medical, Inc. | FRN |
| Nov 15, 1995 | K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER River Medical, Inc. | FRN |
| Oct 17, 1995 | K953660 | PLUM XL INFUSION PUMP (MODIFICATION) Abbott Laboratories | FRN |
| Oct 17, 1995 | K953382 | ACCUPUMP 901 (MODEL NUMBERS 50 & 100) Pharmaceutical Infusion Technologies, Inc. | FRN |
| Oct 7, 1995 | K953270 | MODEL 1100 MEDMATE INFUSION PUMP Patient Solutions, Inc. | FRN |
| Oct 7, 1995 | K943952 | DISETRONIC D-MODEM Disetronic Medical Systems | FRN |
| Sep 19, 1995 | K933825 | ADI SYSTEM Abbott Laboratories | FRN |
| Sep 15, 1995 | K952794 | HARVARD 2 SYRINGE PUMP Harvard Apparatus, Inc. | FRN |
| Aug 11, 1995 | K944721 | 9000 INFUSION PUMP Graseby Medical , Ltd., GB | FRN |
| Jul 24, 1995 | K944669 | FLEXIFLO QUANTUM ENTERAL PUMP Abbott Mfg., Inc. | FRN |
| Jul 10, 1995 | K945942 | AUTO SYRINGE(R) AS50 INFUSION PUMP Baxter Healthcare Corp | FRN |
| Jun 21, 1995 | K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp. | FRN |
| Jun 19, 1995 | K944750 | CORFLO 300 PUMP Corpak, Inc. | FRN |
| May 23, 1995 | K944190 | LIFECARE 175 INFUSER, MODIFICATION Abbott Laboratories | FRN |
| Apr 28, 1995 | K943692 | SMART DOSE(TM) River Medical, Inc. | FRN |
| Mar 22, 1995 | K950766 | SIGMA 8000 AND SIGMA 8002 Sigma Intl. General Medical Apparatus, Inc. | FRN |
| Mar 1, 1995 | K942378 | POCKET PUMP Baxa Infusion Systems | FRN |
| Feb 8, 1995 | K944733 | PLUM XL INFUSION PUMP Abbott Laboratories | FRN |
| Dec 19, 1994 | K941595 | MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5 Microject, Inc. | FRN |
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