Panels › General Hospital › Product code MEB · Class 2
Pump, Infusion, Elastomeric
Regulation 880.5725
1510(k)s in 12 months (88 all time)
0recalls in 12 months (109 all time)
94recalls that name a 510(k)
Top companies in MEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 46 |
| I-Flow Corp. | 17 | 11 |
| Baxter Healthcare Corp | 8 | 10 |
| Arrow International Inc | 0 | 17 |
| Symbios Medical Products, LLC | 3 | 12 |
| Novacon Corp. | 6 | 0 |
| Advanced Infusion, Inc. | 5 | 0 |
| Breg, Inc. | 5 | 0 |
| Hsmg, Inc. D/b/a Smartinfuser Usa | 0 | 4 |
| B.Braun Medical, Inc. | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2000 | K000263 | GO MEDICAL BALLOON INFUSION SYSTEM Go Medical Industries Pty. , Ltd., AU | MEB |
| Feb 9, 2000 | K993832 | AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 Tandem Medical, Inc. | MEB |
| Feb 7, 2000 | K993972 | DISPOSABLE INFUSION PUMP KIT Biomet, Inc. | MEB |
| Oct 27, 1999 | K992551 | ALPHA INFUSION PUMP Advanced Infusion, Inc. | MEB |
| Oct 25, 1999 | K991543 | INTRAOP CATHETER I-Flow Corp. | MEB |
| Sep 10, 1999 | K992015 | FREEDOM INFUSION SYSTEM Novacon Corp. | MEB |
| Jun 30, 1999 | K990461 | MCKINLEY SP DISPOSABLE INFUSION PUMP Mckinley, Inc. | MEB |
| Jun 3, 1999 | K990889 | AUTODOSE INFUSION SYSTEM Tandem Medical, Inc. | MEB |
| Mar 4, 1999 | K984502 | NERVE BLOCK INFUSION KIT I-Flow Corp. | MEB |
| Feb 24, 1999 | K983634 | PREPARE HOME INFUSION PUMP Medical Infusion Technologies, Inc. | MEB |
| Dec 16, 1998 | K983454 | PAIN CARE 2000 Breg, Inc. | MEB |
| Nov 18, 1998 | K982946 | PAINBUSTER INFUSION KIT I-Flow Corp. | MEB |
| Sep 30, 1998 | K982256 | OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP Mckinley, Inc. | MEB |
| Sep 4, 1998 | K982102 | SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY Baxter Healthcare Corp | MEB |
| May 28, 1998 | K980558 | PAINBUSTER INFUSION SYSTEM I-Flow Corp. | MEB |
| Feb 20, 1998 | K972158 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES Princeton Regulatory Assoc. | MEB |
| Dec 4, 1997 | K971362 | PERSONAL INFUSOR Science Incorporated | MEB |
| Aug 15, 1997 | K972173 | MEDI-SIS SYRINGE INFUSION SYSTEM I-Flow Corp. | MEB |
| Jul 15, 1997 | K971168 | ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE Baxter Healthcare Corp | MEB |
| Jun 19, 1997 | K965222 | MICROJECT MODEL PCA-1 Microject, Inc. | MEB |
| Oct 4, 1996 | K963355 | SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET Solopak Medical Products, Inc. | MEB |
| Oct 4, 1996 | K962663 | SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET Solopak Medical Products, Inc. | MEB |
| Aug 5, 1996 | K960318 | DIB INFUSOR-RA Novacon Corp. | MEB |
| Aug 5, 1996 | K955849 | DIB INFUSOR Novacon Corp. | MEB |
| Feb 8, 1996 | K955727 | BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET I-Flow Corp. | MEB |
| Sep 29, 1995 | K954059 | TITAN 20 CC DRIVER I-Flow Corp. | MEB |
| Sep 28, 1995 | K953028 | TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET I-Flow Corp. | MEB |
| Jul 18, 1995 | K941418 | INFUSION PUMP I-Flow Corp. | MEB |
| Feb 14, 1995 | K944665 | DIB INFUSORS Novacon Corp. | MEB |
| Nov 3, 1994 | K943664 | INTERMATE XLV ELASTOMERIC INFUSION SYSTEM Baxter Healthcare Corp | MEB |
| Sep 2, 1994 | K940406 | DISPOSABLE, AMBULATORY, INFUSION PUMPS Vlv Associates, Inc. | MEB |
| Aug 5, 1994 | K941766 | DIB INFUSOR Novacon Corp. | MEB |
| Jun 10, 1994 | K940117 | MID-500 Block Medical, Inc. | MEB |
| Feb 25, 1994 | K930404 | DIB INFUSOR Novacon Corp. | MEB |
| Feb 5, 1993 | K922382 | INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE Baxter Healthcare Corp | MEB |
| Oct 5, 1992 | K914148 | PRIME CADI-120 Prime Medical Products, Inc. | MEB |
| Jul 17, 1992 | K911636 | GENESIS(TM) INFUSION SYSTEM Norman'S | MEB |
| Mar 26, 1992 | K913658 | IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD Imed Corp. | MEB |
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