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 4, 1991 | K904922 | INFUSA D.SLT SYRINGE INFUSION PUMP Ferguson Medical | FRN |
| Aug 26, 1991 | K912928 | LIFECARE 4100 PCA INFUSER PLUS II Abbott Laboratories | FRN |
| Aug 22, 1991 | K912914 | DANBY-DCR VOLUMETRIC INFUSION PUMP Danby Medical , Ltd. | FRN |
| Aug 20, 1991 | K912875 | AVI MODEL 270CI INFUSION PUMP 3M Avi, Inc. | FRN |
| Aug 12, 1991 | K912738 | AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS 3M Avi, Inc. | FRN |
| Aug 2, 1991 | K912092 | MODIFIED LIFECARE MODEL 175 INFUSER Abbott Laboratories | FRN |
| Aug 2, 1991 | K911964 | MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM Abbott Laboratories | FRN |
| Jul 15, 1991 | K905713 | BARD AMBULATORY PUMP TUBING SET C.R. Bard, Inc. | FRN |
| Jul 12, 1991 | K905778 | EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT Baxter Healthcare Corp | FRN |
| Jun 24, 1991 | K912458 | MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED Medtronic Minimed | FRN |
| Jun 24, 1991 | K910934 | FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM Baxter Healthcare Corp | FRN |
| Jun 24, 1991 | K904890 | BARD ALFENTANIL INFUSER C.R. Bard, Inc. | FRN |
| Jun 18, 1991 | K912031 | AVI MODEL 870 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. | FRN |
| Jun 3, 1991 | K911769 | RATEMINDER(TM) V INFUSION PUMP, MODIFICATION Critikon Company, LLC | FRN |
| May 31, 1991 | K910844 | INFUSION PUMP Technology Transfer Intl., Inc. | FRN |
| May 31, 1991 | K910024 | VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp | FRN |
| May 30, 1991 | K910758 | MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11 Technology Transfer Intl., Inc. | FRN |
| May 30, 1991 | K910350 | MICREL LTD-PORTABLE INFUSION PUMP-MP20Q Technology Transfer Intl., Inc. | FRN |
| May 28, 1991 | K911401 | ABBOTT LIFECARE 5000 PUMP Abbott Laboratories | FRN |
| May 23, 1991 | K910919 | ABBOTT LIFECARE 5000 PUMP MODIFIED Abbott Laboratories | FRN |
| May 21, 1991 | K911289 | EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP Baxter Healthcare Corp | FRN |
| May 13, 1991 | K910637 | MENTOR(R) SUR-E-TROL(R) Mentor O & O, Inc. | FRN |
| Apr 19, 1991 | K902613 | BARD PCA II PUMP WITH PROGRAM CARTRIDGES C.R. Bard, Inc. | FRN |
| Apr 8, 1991 | K910428 | EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp | FRN |
| Apr 1, 1991 | K910425 | LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. Baxter Healthcare Corp | FRN |
| Mar 21, 1991 | K910523 | MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS Baxter Healthcare Corp | FRN |
| Mar 13, 1991 | K910335 | MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA Medical Technical Products | FRN |
| Mar 8, 1991 | K905696 | STRATOFUSE PCA INFUSER Strato Medical Corp. | FRN |
| Mar 1, 1991 | K905611 | MICRORATE PLUS INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. | FRN |
| Mar 1, 1991 | K905610 | MICRORATE INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. | FRN |
| Feb 7, 1991 | K905251 | MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A Medical Technical Products | FRN |
| Feb 1, 1991 | K903571 | MICREL LTD PORTABLE INFUSION MICROPUMP Technology Transfer Intl., Inc. | FRN |
| Jan 15, 1991 | K904979 | AVI MODEL 600 SYRINGE PUMP, MODIFICATION 3M Avi, Inc. | FRN |
| Jan 11, 1991 | K905783 | MODIFIED WALKMED 400 Medfusion, Inc. | FRN |
| Dec 28, 1990 | K904403 | BARD AMBULATORY PCA DRUG DELIVERY SYSTEM C.R. Bard, Inc. | FRN |
| Dec 24, 1990 | K905029 | MODEL 2001, MODIFICATION Medfusion, Inc. | FRN |
| Nov 21, 1990 | K903343 | SYRINGE INFUSION PUMP Baxter Healthcare Corp | FRN |
| Nov 21, 1990 | K902891 | VERIFUSE AMBULATORY PUMP Block Medical, Inc. | FRN |
| Oct 31, 1990 | K900217 | BARD MICROBORE ANTI-SIPHON NITRO SET C.R. Bard, Inc. | FRN |
| Oct 17, 1990 | K904518 | VOLUMETRIC INFUSION PUMP Kendall Mcgaw Laboratories, Inc. | FRN |
| Oct 4, 1990 | K901550 | IVAC(R) SYRINGE PUMP - MODEL 770 Y | FRN |
| Oct 3, 1990 | K903879 | IVAC(R) SYRINGE PUMP - MODEL 740 Y | FRN |
| Oct 1, 1990 | K904048 | MULTI DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
| Sep 28, 1990 | K901978 | MULTI-DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
| Sep 28, 1990 | K897086 | PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 Parker Hannifin Corp. | FRN |
| Sep 19, 1990 | K902432 | AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET Abbott Laboratories | FRN |
| Sep 14, 1990 | K902374 | CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM Pharmacia Deltec, Inc. | FRN |
| Sep 5, 1990 | K903787 | AVI MODEL 470CM INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 5, 1990 | K903786 | AVI MICRO 845 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. | FRN |
| Sep 5, 1990 | K903785 | AVI MODEL 400CM INFUSION PUMP 3M Avi, Inc. | FRN |
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