Panels › General Hospital › Product code FLE · Class 2
Sterilizer, Steam
Regulation 880.6880
4510(k)s in 12 months (185 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in FLE
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 23 | 10 |
| Tuttnauer , Ltd. | 18 | 0 |
| Scican | 13 | 2 |
| Midmark Corp. | 9 | 1 |
| Fort Defiance Industries, Inc. | 3 | 3 |
| Getinge/Castle, Inc. | 6 | 0 |
| Primus Sterilizer Co., Inc. | 6 | 0 |
| Castle Co. | 5 | 0 |
| Getinge Sourcing, LLC | 5 | 0 |
| Sauter AG | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 1990 | K901147 | JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT Joslyn Valve Corp. | FLE |
| Nov 23, 1990 | K895275 | MAC LAVE STEAM STERILIZER Merchants Export Development Corp. | FLE |
| Nov 7, 1990 | K903613 | HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) Harvard Apparatus, Inc. | FLE |
| Oct 1, 1990 | K903096 | RACK-IT (R) Vengo Industries, Inc. | FLE |
| Jul 27, 1990 | K900432 | MODEL #M8 ELECTRONIC STERILIZER Midmark Corp. | FLE |
| Feb 22, 1990 | K895638 | STEAM STERILIZER (AUTOCLAVE), DENTAL Porter Instrument Co., Inc. | FLE |
| Dec 11, 1989 | K895848 | PRESSURE STEAM STERILIZERS Scientific Device Laboratory, Inc. | FLE |
| Aug 21, 1989 | K893886 | MITEK STERILIZATION TRAY Mitek Surgical Products, Inc. | FLE |
| Aug 7, 1989 | K890359 | RESUBMITTED STC SERIES 8600 AUTOCLAVE Sterilizer Technologies Corp. | FLE |
| Mar 29, 1989 | K885140 | MULTI-PURPOSE CONTROL SYSTEM Colliers Sterilizer Sales & Service Co., Inc. | FLE |
| Aug 12, 1988 | K882713 | REBUILDING STERILIZERS Mdt Corp., Inc. | FLE |
| Jun 24, 1988 | K882465 | MODEL 172-P AND 172-N ROTARY SPRAY ARM Boling Precision Components Co. | FLE |
| Jan 27, 1988 | K874644 | STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON Pharmetics, Inc. | FLE |
| Apr 17, 1987 | K870975 | MODIFIED CASTLE POWERCLAVE Castle Co. | FLE |
| Oct 22, 1986 | K862495 | STARCRAFT ELITE AUTOCLAVE Starcraft Medical Corp. | FLE |
| Sep 27, 1985 | K852114 | ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 Ars Enterprises, Inc. | FLE |
| Sep 27, 1985 | K852113 | ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 Ars Enterprises, Inc. | FLE |
| Aug 5, 1985 | K844649 | ELECTRICALLY HEATED STERILIZER STEAM STERILIZER Takizawa Medical Instruments Manufacturer | FLE |
| Jun 4, 1985 | K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE Tuttnauer Co. , Ltd., IL | FLE |
| Jul 26, 1984 | K842631 | STERELIS SEALING EQUIPMENT Sterelis Corp. | FLE |
| Jul 18, 1984 | K831356 | STEAM STERILIZER Ars Enterprises, Inc. | FLE |
| Mar 19, 1984 | K834152 | ETHYLENE OXIDE DETECTOR GLD-1-07 Calnor of EL Paseo, Inc. | FLE |
| Jan 11, 1984 | K833837 | AMERICAN GOLD SERIES AUTOCLAVE Tuttnauer Co. , Ltd. | FLE |
| Jul 27, 1983 | K830931 | PORTABLE AUTOCLAVES Arnold & Sons | FLE |
| Feb 23, 1983 | K823457 | NON-PRESSURE AUTOCLAVE FOR STERILIZATION Interdent, Inc. | FLE |
| Jun 22, 1982 | K821591 | STEAM STERILIZATION EQUIPMENT Getinge International, Inc. | FLE |
| Jun 20, 1980 | K801309 | RITTER STERILIZER Sybron Corp. | FLE |
| Jan 28, 1980 | K800080 | STERILIZING CASE CAT. NO. 65199 Edward Weck, Inc. | FLE |
| Dec 27, 1979 | K792558 | CONTAINER SYSTEM Aesculap Instruments Corp. | FLE |
| Oct 24, 1978 | K781684 | STERILIZER, EAGLE 2000 American Sterilizer Co. | FLE |
| Aug 2, 1977 | K771229 | STERILIZERS, 3100 SERIES TRIM LINE Castle Co. | FLE |
| May 20, 1977 | K770682 | STERILIZER, SERIES 3000, MODIFICATION TO Castle Co. | FLE |
| Apr 29, 1977 | K770536 | STEAM STERILIZER, 3000 Castle Co. | FLE |
| Apr 5, 1977 | K770372 | STERILIZER, STEAM, CASTLE 3000 Castle Co. | FLE |
| Jan 26, 1977 | K761032 | CRADLING SYSTEM Medin Corp. | FLE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.