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 9, 1994 | K931318 | 3400 INFUSION PUMP Graseby Medical , Ltd., GB | FRN |
| Dec 6, 1994 | K944125 | ABBOTT LTE INFUSION PUMP Abbott Laboratories | FRN |
| Oct 20, 1994 | K942162 | SIGMA 8000 AND SIGMA 8002 Sigma Intl. | FRN |
| Sep 29, 1994 | K933545 | SIEMENS FLUID DELIVERY SYSTEM, MMT-9500 Siemens Infusions Systems | FRN |
| Aug 15, 1994 | K940446 | 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION) Minnesota Mining and Mfg. Co. | FRN |
| Aug 2, 1994 | K942161 | LOCKBOX Pharmacia Deltec, Inc. | FRN |
| Jul 19, 1994 | K941984 | SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP Sabratek Corp. | FRN |
| Jul 13, 1994 | K922702 | PROVIDER ANNE INFUSER Abbott Laboratories | FRN |
| Jul 7, 1994 | K941151 | STRATOFUSE PCA II INFUSER Infusion Technology Intl. | FRN |
| Jun 17, 1994 | K932847 | CORPAK ENTERAL PUMP Corpak Co. | FRN |
| May 18, 1994 | K933652 | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING Repro-Med Systems, Inc. | FRN |
| Apr 26, 1994 | K930495 | PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP Elan Medical Technologies, Ltd. | FRN |
| Apr 26, 1994 | K930494 | PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION Elan Medical Technologies, Ltd. | FRN |
| Apr 18, 1994 | K926385 | BARD APII PUMP C.R. Bard, Inc. | FRN |
| Apr 15, 1994 | K940147 | AUTO SYRINGE AS40A INFUSION PUMP Baxter Corp. | FRN |
| Mar 31, 1994 | K932895 | RIVER PUMP River Medical, Inc. | FRN |
| Mar 31, 1994 | K931458 | MEDIPAK AMBULATORY INFUSION PUMP Medication Delivery Devices, Inc. | FRN |
| Mar 31, 1994 | K924603 | PHARMETRIX MINIPUMP MODEL 5120 Pharmetrix, Inc. | FRN |
| Mar 29, 1994 | K924527 | VIVUS 5000 INFUSION SYSTEM I-Flow Corp. | FRN |
| Mar 14, 1994 | K934671 | HI-FLO INFUSION PUMP Abbott Laboratories | FRN |
| Mar 7, 1994 | K915649 | BARD 500ML RESERVOIR HOLDER C.R. Bard, Inc. | FRN |
| Feb 25, 1994 | K933506 | SYRINGE INFUSER Baxa Corp. | FRN |
| Feb 24, 1994 | K923224 | KVOI.V. FLUSH SYSTEM Baxter Healthcare Corp | FRN |
| Nov 2, 1993 | K910007 | SPRINGFUSOR 10R Go Medical Industries Pty. , Ltd., AU | FRN |
| Oct 27, 1993 | K923290 | COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE A Mixed Bag Corp. | FRN |
| Oct 25, 1993 | K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE 3M Health Care, Ltd. | FRN |
| Oct 25, 1993 | K933005 | AVI MODEL 600 SYRINGE PUMP 3M Health Care, Ltd. | FRN |
| Oct 12, 1993 | K933144 | GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER Imed Corp. | FRN |
| Oct 12, 1993 | K932544 | IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 Y | FRN |
| Oct 12, 1993 | K931549 | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP Y | FRN |
| Sep 16, 1993 | K922670 | THE MINIMED MODEL 404-SP AND 504-S Medtronic Minimed | FRN |
| Sep 10, 1993 | K921901 | PORT ACCESS INFUSION SET Kawasumi Laboratories Co., Ltd., JP | FRN |
| Sep 1, 1993 | K931375 | ABBOTT PLUM XL INFUSION PUMP Abbott Laboratories | FRN |
| Aug 31, 1993 | K926191 | SIGMA 7000 AND SIGMA70002 Sigma | FRN |
| Aug 20, 1993 | K931132 | CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. | FRN |
| Aug 19, 1993 | K930781 | INFUSION PUMP Y | FRN |
| Aug 16, 1993 | K925311 | TRILOGY INFUSION PUMP Ivion Corp. | FRN |
| Aug 10, 1993 | K930459 | BARD MINI-INFUSER 1500 & 3000 Bard Medsystems Div. | FRN |
| Aug 3, 1993 | K921050 | ULTRAFLO RATESAVER PLUS INFUSION PUMP Clinical Systems, Inc. | FRN |
| Jul 8, 1993 | K925091 | IVAC SYRING PUMP MODEL 770 Y | FRN |
| Jun 18, 1993 | K925196 | BARD EPIDURAL PUMP C.R. Bard, Inc. | FRN |
| Jun 18, 1993 | K925112 | BIO CLINIC UNDER PATIENT SCALE Sunrise Medical, Inc. | FRN |
| Jun 18, 1993 | K924871 | MODEL 880 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924872 | MODEL 885 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924870 | MODEL 480CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924869 | MODEL 480CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924868 | MODEL 480 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924867 | 285CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924866 | MODEL 285CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924865 | MODEL 285 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.