Panels › General Hospital › Product code MED · Class 2
Sterilant, Medical Devices
Regulation 880.6885
2510(k)s in 12 months (65 all time)
0recalls in 12 months (21 all time)
18recalls that name a 510(k)
Top companies in MED
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 19 | 8 |
| Advanced Sterilization Products | 5 | 4 |
| Best Sanitizers, Inc. | 2 | 1 |
| Cottrell, Ltd. | 3 | 0 |
| Metrex Research Corp. | 3 | 0 |
| Steris Corporation Hopkins Facility | 0 | 3 |
| Ciden Technologies, LLC | 2 | 0 |
| Healthpoint, Ltd. | 2 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 2 |
| Minntech Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 1998 | K970726 | VAPOCIDE Cottrell, Ltd. | MED |
| Dec 4, 1997 | K961289 | VAPOPHENE Germiphene Corp., CA | MED |
| Oct 29, 1997 | K970230 | SPOROX Reckitt Benckiser, Inc. | MED |
| Oct 1, 1997 | K960513 | PERACT 20 LIQUID STERILANT Minntech Corp. | MED |
| Aug 10, 1995 | K914749 | WAVICIDE(R) -01 Wave Energy Systems, Inc. | MED |
| Jul 3, 1995 | K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR Cottrell, Ltd. | MED |
| Dec 6, 1994 | K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE Metrex Research Corp. | MED |
| Dec 6, 1994 | K931052 | METRICIDE 28 Metrex Research Corp. | MED |
| Dec 6, 1994 | K930284 | METRICIDE Metrex Research Corp. | MED |
| Jun 2, 1994 | K932047 | WAVICIDE MONITOR STRIPS Serim Research Corp. | MED |
| Mar 29, 1994 | K924334 | CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE Johnson & Johnson Medical, Inc. | MED |
| Oct 6, 1993 | K932740 | HOMEPUMP NSF Block Medical, Inc. | MED |
| Jul 28, 1992 | K915170 | PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR Pymah Corp. | MED |
| Mar 26, 1992 | K913943 | SERIM DISINTEK REAGENT STRIPS Serim Research Corp. | MED |
| Sep 13, 1988 | K875280 | STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT Steris C/O Medical Device Consultants, Inc. | MED |
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