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 |
|---|---|---|---|
| Jun 17, 2015 | K141879 | BELIMED STEAM STERILIZER MST-H Sauter AG, CH | FLE |
| Jan 20, 2015 | K140736 | STERISAFE HP TABLE-TOP STEAM STERILIZER Milton E Pedrazzi D.D.S., Inc. | FLE |
| Jan 15, 2015 | K143311 | Pre-vacuum Tabletop Autoclave Tuttnauer U.S.A Co, Ltd. | FLE |
| Dec 16, 2014 | K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc. | FLE |
| Jan 6, 2014 | K132439 | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER Sakura Seiki Co., Ltd. | FLE |
| Sep 23, 2013 | K130172 | BELIMED STEAM STERILIZER MST-V Belimed, Inc. | FLE |
| May 23, 2013 | K122978 | SANICLAVE 102, MODEL RS-SC-102 Alternative Pioneering Research and Development | FLE |
| May 22, 2013 | K122625 | GETINGE 800HC- SERIES STEAM STERILIZER Getinge Sourcing, LLC | FLE |
| May 9, 2013 | K122774 | SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG Sakura Seiki Co., Ltd., JP | FLE |
| Mar 12, 2013 | K122071 | GETINGE 400HC-E / SERIES STEAM STERILIZER Getinge Sourcing, LLC | FLE |
| Jul 10, 2012 | K112872 | STATIM 2000 G4 CASSETTE Scican , Ltd., CA | FLE |
| May 31, 2012 | K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER Getinge Sourcing, LLC | FLE |
| May 8, 2012 | K120149 | SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA Sakura Seiki Co., Ltd. | FLE |
| May 8, 2012 | K112403 | AMSCO CHIMERON MEDIUM STEAM STERLILZER STERIS Corporation | FLE |
| Jan 11, 2012 | K112811 | SANICLAVE 200 Alternative Pioneering Research and Development | FLE |
| Dec 16, 2011 | K112055 | AMSCO CHIMERON MEDIUM STEAM STERILIZER STERIS Corporation | FLE |
| Dec 8, 2011 | K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES Tuttnauer Co. , Ltd. | FLE |
| Sep 20, 2011 | K111223 | AMSCO CHIMERON SMALL STEAM STERILIZER STERIS Corporation | FLE |
| Mar 16, 2011 | K103504 | GETINGE 400HC/500HC SERIES STEAM STERILIZER Getinge Sourcing, LLC | FLE |
| Mar 15, 2011 | K103841 | BELIMED STEAM STERILIZER MST-V Sauter AG, CH | FLE |
| Aug 27, 2010 | K100622 | BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 Belimed Sauter AG, CH | FLE |
| Apr 2, 2010 | K093333 | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 Primus Sterilizer Company, LLC | FLE |
| Nov 4, 2009 | K092490 | AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 STERIS Corporation | FLE |
| Sep 23, 2009 | K090339 | BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 Belimed Sauter AG | FLE |
| Sep 17, 2009 | K091731 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation | FLE |
| Aug 20, 2009 | K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE Tuttnauer U.S.A Co, Ltd. | FLE |
| Jul 7, 2009 | K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER Midmark Corp. | FLE |
| Jun 29, 2009 | K091136 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 STERIS Corporation | FLE |
| May 21, 2009 | K082817 | PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M Primus Sterilizer Company, LLC | FLE |
| May 15, 2009 | K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V Scican , Ltd., CA | FLE |
| Dec 30, 2008 | K082435 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation | FLE |
| Dec 19, 2007 | K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 Scican , Ltd., CA | FLE |
| Oct 5, 2007 | K072087 | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 Belimed Sauter AG, CH | FLE |
| Jun 29, 2007 | K063681 | TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE Mediline Italia S.R.L. | FLE |
| Apr 5, 2007 | K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER Getinge Sourcing, LLC | FLE |
| Feb 2, 2007 | K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA Tuttnauer Co. , Ltd. | FLE |
| Nov 21, 2006 | K050263 | MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU M.O. Com S.R.L., IT | FLE |
| Sep 5, 2006 | K052532 | IMAX 9.5 STERILIZERS Dental X Srl | FLE |
| Mar 8, 2006 | K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 Sauter AG, CH | FLE |
| Dec 10, 2004 | K041833 | CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER Consolidated Machine Corp. | FLE |
| Aug 12, 2004 | K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V Tuttnauer U.S.A Co, Ltd. | FLE |
| Feb 2, 2004 | K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 Sauter AG, CH | FLE |
| Oct 1, 2003 | K024133 | CLS-2000 UNIT Dentsply Intl. | FLE |
| May 12, 2003 | K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER Getinge USA, Inc. | FLE |
| Mar 26, 2003 | K030789 | AMSCO CENTURY STEAM STERILIZER STERIS Corporation | FLE |
| Mar 3, 2003 | K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Feb 7, 2003 | K022816 | W & H LISA STEAM STERILIZER A-Dec, Inc. | FLE |
| Aug 8, 2002 | K021064 | QUANTIM 16 AUTOCLAVE Scican, CA | FLE |
| Jul 25, 2002 | K021504 | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 Tuttnauer U.S.A Co, Ltd. | FLE |
| Jun 26, 2002 | K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 Sauter AG, CH | FLE |
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