Company ยท US
Waters Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2006. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQA | Oximeter | 3 |
| KDN | System, Perfusion, Kidney | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DYG | Catheter, Flow Directed | 1 |
| KDK | Container, Transport, Kidney | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KPH | Catheter, Rectal For Continent Ileostomy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2006 | K053169 | RM3 RENAL PRESERVATION SYSTEM Waters Instruments, Inc. | KDK |
| Oct 22, 2004 | K042224 | RM3 RENAL PRESERVATION SYSTEM Waters Instruments, Inc. | KDN |
| Jul 29, 1997 | K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT Waters Instruments, Inc. | KDN |
| Oct 23, 1992 | K921519 | OXICOM-2100 Waters Instruments, Inc. | DQA |
| Aug 26, 1991 | K911207 | OXICOMPLUS Waters Instruments, Inc. | DQA |
| Nov 26, 1986 | K863210 | VELCOM-100 Waters Instruments, Inc. | DPW |
| Aug 18, 1986 | K862161 | OSC-80 OXIMETER Waters Instruments, Inc. | DQA |
| Nov 14, 1985 | K852909 | MVP - 6000 Waters Instruments, Inc. | BZC |
| Aug 23, 1984 | K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT Waters Instruments, Inc. | DXG |
| Jul 13, 1984 | K841876 | POLYURETHANE THERMAL DILUTION CATHET Waters Instruments, Inc. | DYG |
| Apr 9, 1982 | K813585 | WATERS ILEOSTOMY VALVE Waters Instruments, Inc. | KNT |
| Dec 31, 1981 | K813494 | WATERS ILEAL RESERVOIR CATHETER Waters Instruments, Inc. | KPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||