Panels › Gastroenterology, Urology › Product code LIF · Class 2
Dialyzer Reprocessing System
Regulation 876.5820
0510(k)s in 12 months (57 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LIF
| Company | 510(k)s | Recalls |
|---|---|---|
| Seratronics, Inc. | 9 | 0 |
| Renal Systems, Inc. | 6 | 0 |
| Serim Research Corp. | 5 | 0 |
| Colorado Medical, Inc. | 4 | 0 |
| Computer Dialysis Systems, Inc. | 3 | 0 |
| Mesa Medical, Inc. | 3 | 0 |
| Minntech Corp. | 3 | 0 |
| Alcavis International Incorporated | 2 | 0 |
| Hach Company | 1 | 1 |
| Medicorp, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 1982 | K821863 | DIALYZER REPROCESSING SYSTEM DRS-4 Seratronics, Inc. | LIF |
| Jun 23, 1982 | K821383 | ECHO, MODEL MM-1000 Mesa Medical, Inc. | LIF |
| Apr 29, 1982 | K820695 | AUTOMATIC DIALYZER REPROCESSOR #ADR-22 Texas Medical Devices, Inc. | LIF |
| Mar 23, 1982 | K820221 | HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE Renal Systems, Inc. | LIF |
| Mar 23, 1982 | K813107 | COMPUDIAL/KP-1 Computer Dialysis Systems, Inc. | LIF |
| Nov 6, 1981 | K812230 | MODEL RS 8300 Renal Systems, Inc. | LIF |
| May 8, 1981 | K802828 | LIXIVITRON United Medical | LIF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.