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 |
|---|---|---|---|
| May 17, 2002 | K020747 | AMSCO CENTURY MEDIUM STERILIZER 26 X 26 STERIS Corporation | FLE |
| Mar 20, 2002 | K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER Getinge/Castle, Inc. | FLE |
| Feb 22, 2002 | K014174 | HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 Barnstead/Thermolyne Corp. | FLE |
| Sep 5, 2001 | K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC Getinge/Castle, Inc. | FLE |
| May 31, 2001 | K010865 | AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY STERIS Corporation | FLE |
| Feb 20, 2001 | K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 Tuttnauer Co. , Ltd. | FLE |
| Feb 9, 2001 | K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP Tuttnauer U.S.A Co, Ltd. | FLE |
| Jan 2, 2001 | K003441 | CASTLE MODEL 233HC STEAM STERILIZER Getinge/Castle, Inc. | FLE |
| Mar 17, 2000 | K000077 | STERIS AMSCO MILLENNIUM STEAM STERILIZER STERIS Corporation | FLE |
| Feb 16, 2000 | K994314 | CASTLE SERIES 100HC STEAM STERILIZERS Getinge/Castle, Inc. | FLE |
| Jan 10, 2000 | K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Dec 3, 1999 | K991575 | PRIMUS STEAM STERILIZERS Primus Sterilizer Co., Inc. | FLE |
| Apr 19, 1999 | K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Jan 20, 1999 | K982332 | STERIS TEN SIXTEEN STEAM STERILIZER STERIS Corporation | FLE |
| Jan 4, 1999 | K983679 | STATIM 5000 CASSETTE AUTOCLAVE Scican, CA | FLE |
| Jun 1, 1998 | K964332 | EAGLE CENTURY STEAM STERILIZER Amsco Intl., Inc. | FLE |
| May 15, 1998 | K980014 | THE SYSTEM 2S STEAM STERILIZER STERIS Corporation | FLE |
| Mar 3, 1998 | K962903 | PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE Prestige Medical Corp. | FLE |
| Feb 10, 1998 | K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) Getinge/Castle, Inc. | FLE |
| Nov 12, 1997 | K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) Getinge/Castle, Inc. | FLE |
| Nov 12, 1997 | K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE Tuttnauer U.S.A Co, Ltd. | FLE |
| Oct 29, 1997 | K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE Tuttnauer U.S.A Co, Ltd. | FLE |
| Jun 6, 1997 | K954142 | STERRADD STERILIZATION SYSTEM Advanced Sterilization Products | FLE |
| Mar 4, 1997 | K962755 | STRYKER ENCORE STERILIZER Stryker Corp. | FLE |
| Feb 28, 1997 | K945117 | DELTA Pelton & Crane Co. | FLE |
| Jan 30, 1997 | K953938 | STERILEMAX Barnstead/Thermolyne Corp. | FLE |
| Jan 13, 1997 | K962179 | STAT IM 5000 CASSETTE AUTOCLAVE Scican | FLE |
| Oct 2, 1996 | K944036 | STERIMASTER AUTOCLAVE Scican, CA | FLE |
| Aug 15, 1996 | K954736 | ACCESS (POWERCLAVE) Mdt Biologic Co. | FLE |
| Jun 27, 1996 | K961230 | EASTERCLAVE Easter Services, Inc. | FLE |
| Sep 29, 1995 | K951557 | EASTERCLAVE Easter Services, Inc. | FLE |
| Aug 8, 1995 | K951273 | BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER Buxton Medical Servic Corp. | FLE |
| Jul 7, 1995 | K942989 | OCR II & OCM II Chambermaid Products Co. | FLE |
| Apr 19, 1995 | K950341 | BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER Barnard and Assoc. | FLE |
| Nov 30, 1994 | K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| May 9, 1994 | K926185 | PRIMUS PSS SERIES STERILIZERS Primus Sterilizer Co., Inc. | FLE |
| Apr 15, 1994 | K924596 | SES-2012 AUTOMATIC STEAM STERILIZER Porter Instrument Co., Inc. | FLE |
| Oct 15, 1993 | K924955 | MDT/HARVEY MC-8 AND MC-10 Mdt Corp., Inc. | FLE |
| Jul 8, 1993 | K920478 | TUTTNAUER LSI (AUTOMATIC) Tuttnauer Co. , Ltd. | FLE |
| Jan 29, 1993 | K921613 | STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 Dept. of the Army | FLE |
| Aug 4, 1992 | K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION Scican, CA | FLE |
| Jun 26, 1992 | K912471 | EAGLE 3000 SDS Amsco Co. | FLE |
| Apr 21, 1992 | K920293 | DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY Davis & Geck, Inc. | FLE |
| Mar 27, 1992 | K910777 | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER Mdt Biologic Co. | FLE |
| Nov 29, 1991 | K911206 | MAXIMA-10 Stirn Industries | FLE |
| Oct 28, 1991 | K910778 | STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) Mdt Biologic Co. | FLE |
| Aug 26, 1991 | K911322 | MODEL #M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Aug 26, 1991 | K910789 | KAVOKLAVE STEAM AUTOCLAVE Kavo America | FLE |
| May 3, 1991 | K910241 | STATIM CASSETTE AUTOCLAVE Scican, CA | FLE |
| Dec 14, 1990 | K903614 | HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE Harvard Apparatus, Inc. | FLE |
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