Panels › Gastroenterology, Urology › Product code MQS · Class 2
System, Hemodialysis, Access Recirculation Monitoring
Regulation 876.5820
0510(k)s in 12 months (18 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MQS
| Company | 510(k)s | Recalls |
|---|---|---|
| In-Line Diagnostics Corp. | 5 | 0 |
| Transonic Systems, Inc. | 4 | 1 |
| Hewlett-Packard Co. | 2 | 0 |
| Cobe Renal Care, Inc. | 1 | 0 |
| Dosis, Inc. | 1 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| H&H Control Systems | 1 | 0 |
| Physician Software Systems, LLC | 1 | 0 |
| Physicians Software Systems, LLC | 1 | 0 |
| Vasc-Alert, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2023 | K232283 | PhySoftAMS® Physician Software Systems, LLC | MQS |
| Jan 16, 2019 | K180410 | Dosis SAM Dosis, Inc. | MQS |
| Dec 19, 2013 | K130579 | PHYSOFT AMS Physicians Software Systems, LLC | MQS |
| Nov 8, 2004 | K042566 | VASC-ALERT Vasc-Alert, Inc. | MQS |
| Dec 4, 2002 | K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 Transonic Systems, Inc. | MQS |
| Aug 12, 2002 | K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 Transonic Systems, Inc. | MQS |
| Dec 20, 2000 | K001763 | CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. | MQS |
| Jan 20, 2000 | K993587 | HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. | MQS |
| Jul 30, 1999 | K992227 | CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. | MQS |
| Apr 30, 1999 | K984194 | HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. | MQS |
| Oct 9, 1998 | K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. | MQS |
| Oct 6, 1998 | K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO Transonic Systems, Inc. | MQS |
| Dec 11, 1997 | K972470 | CRIT-LINE MONITOR (CLMIII) In-Line Diagnostics Corp. | MQS |
| Feb 11, 1997 | K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) Transonic Systems, Inc. | MQS |
| Feb 6, 1997 | K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR Cobe Renal Care, Inc. | MQS |
| Jul 23, 1996 | K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) In-Line Diagnostics Corp. | MQS |
| Jul 3, 1996 | K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR Fresenius USA, Inc. | MQS |
| Jun 21, 1996 | K953551 | KNOW-RECIRC H&H Control Systems | MQS |
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