FDA 510(k) Applications for Medical Device:
Sterilizer, Steam
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K022816 | A-DEC, INC. |
2601 CRESTVIEW DR. | NEWBERG | OR | 97132-9257 |
| K954142 | ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K122978 | ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT |
17319 LAKE BLVD. | SHAFER | MN | 55074 |
| K112811 | ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT |
17319 LAKE BLVD. | SHAFER | MN | 55074 |
| K964332 | AMSCO INTL., INC. |
2424 W 23RD STREET-AMSCO-620 | ERIE | PA | 16514 |
| K170304 | Astell Scientific Limited |
19-21 Powerscroft Rd | Sidcup | DA14 5DT | |
| K014174 | BARNSTEAD/THERMOLYNE CORP. |
P.O. BOX 797 | DUBUQUE | IA | 52001 |
| K953938 | BARNSTEAD/THERMOLYNE CORP. |
2555 KERPER BLVD. | DUBUQUE | IA | 52001 |
| K170228 | Belimed AG |
Grienbachstrasse 11 | Zug | 6300 | |
| K191896 | Belimed AG |
Grienbachstrasse 11 | Zug | 6300 | |
| K072087 | BELIMED SAUTER AG |
ZELGSTRASSE 8 | SULGEN (TG) | CH-8583 | |
| K090339 | BELIMED SAUTER AG |
2284 CLEMENTS FERRY RD. | CHARLESTON | SC | 29412 |
| K100622 | BELIMED SAUTER AG |
ZELGSTRASSE 8 | SULGEN (TG) | CH-8583 | |
| K130172 | BELIMED, INC. |
2284 Clements Ferry Road | Charleston | SC | 29492 |
| K151597 | CEFLA S.C. |
VIA SELICE PROVINCIALE 23/A | IMOLA | 40026 | |
| K161848 | CEFLA S.C. |
VIA SELICE PROVINCIALE, 23/A | IMOLA | 40026 | |
| K220736 | Consolidated Machine Corp. |
3 Enterprise Rd, Suite C | Billerica | MA | 01821 |
| K041833 | CONSOLIDATED MACHINE CORP. |
76 ASHFORD ST. | BOSTON | MA | 02134 |
| K052532 | DENTAL X SRL |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K024133 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K961230 | EASTER SERVICES, INC. |
306 WEST THIRD ST., 2ND. FLOOR | MILAN | IL | 61264 |
| K210279 | Enbio Group AG |
Eichengasse 3 | Oensingen | CH-4702 | |
| K213991 | Enbio Group AG |
Eichengasse 3 | Oensingen | CH-4702 | |
| K213457 | Fort Defiance Industries LLC |
2411 Maremont Parkway | Loudon | TN | 37774 |
| K243801 | Fort Defiance Industries LLC |
2411 Maremont Parkway | Loudon | TN | 37774 |
| K141009 | Fort Defiance Industries, Inc. |
155 B Natalie BLVD | Loudon | TN | 37774 |
| K122071 | GETINGE SOURCING LLC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K070657 | GETINGE SOURCING LLC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K120441 | GETINGE SOURCING LLC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K122625 | GETINGE SOURCING LLC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K103504 | GETINGE SOURCING, LLC |
1777 EAST HENRIETTA ROAD | ROCHESTER | NY | 14623 |
| K031259 | GETINGE USA, INC |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K012573 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K003441 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K970907 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K994314 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K973225 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K020590 | GETINGE/CASTLE, INC. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623-3133 |
| K050263 | M.O.C.O.M. SRL |
VIA DELLE AZALEE 1 | BUCCINASCO (MI) | 20090 | |
| K201927 | Maquet GmbH |
Kehler Strasse 31 | Rastatt | 76437 | |
| K172159 | Maquet GmbH |
Kehler Strasse 31 | Rastatt | 76437 | |
| K214120 | Maquet GmbH |
Kehler Strasse 31 | Rastatt | 76437 | |
| K954736 | MDT BIOLOGIC CO. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14692 |
| K063681 | MEDILINE ITALIA S.R.L. |
6512 BANNOCKBURN DRIVE | BETHESDA | MD | 20817 |
| K090670 | MIDMARK CORP. |
60 VISTA DR. | VERSAILLES | OH | 45380 |
| K992744 | MIDMARK CORP. |
60 VISTA DR. | VERSAILLES | OH | 45380 |
| K023348 | MIDMARK CORP. |
60 VISTA DR. | VERSAILLES | OH | 45380 |
| K990189 | MIDMARK CORP. |
60 VISTA DR. | VERSAILLES | OH | 45380 |
| K163337 | Midmark Corporation |
60 VISTA DR. | VERSAILLES | OH | 45380 |
| K233026 | Midmark Corporation |
60 Vista Drive | Versailles | OH | 45380 |
| K140736 | MILTON E PEDRAZZI D.D.S., INC. |
6501 CROWN BLVD, SUITE 102 | SAN JOSE | CA | 95120 |
| K243994 | Ningbo Ican Machines Co., Ltd. |
No. 77 Yunlin East Road, Gulin Town, | Ningbo | 315000 | |
| K945117 | PELTON & CRANE CO. |
P.O. BOX 7800 | CHARLOTTE | NC | 28241-7800 |
| K962903 | PRESTIGE MEDICAL CORP. |
1455 PENNSYLVANIA AVE., N.W. | WASHINGTON | DC | 20004 |
| K991575 | PRIMUS STERILIZER CO., INC. |
117 SOUTH 25TH ST. | OMAHA | NE | 68131 |
| K233132 | PRIMUS Sterilizer Company, LLC |
7936 Forest City Road, Suite 100 | Orlando | FL | 32810 |
| K221474 | PRIMUS Sterilizer Company, LLC |
7936 Forest City Road, Suite 100 | Orlando | FL | 32810 |
| K093333 | PRIMUS STERILIZER COMPANY, LLC. |
117 SOUTH 25TH ST. | OMAHA | NE | 68131 |
| K082817 | PRIMUS STERILIZER COMPANY, LLC. |
5520 10TH ST. | GREAT BEND | KS | 67530 |
| K180272 | REVOLUTIONARY SCIENCE |
17319 Lake Blvd | Shafer | MN | 55074 |
| K122774 | SAKURA SEIKI CO., LTD. |
46-1, SHINDEN | CHIKUMA, NAGANO | 387-0018 | |
| K132439 | SAKURA SEIKI CO., LTD. |
55 Northern Blvd | Great Neck | NY | 11021 |
| K120149 | SAKURA SEIKI CO., LTD. |
55 Northern Blvd | Great Neck | NY | 11021 |
| K141879 | SAUTER AG |
ZELGSTRASSE 8 | SULGEN TG | CH-8583 | |
| K103841 | SAUTER AG |
ZELGSTRASSE 8 | SULGEN TG | CH-8583 | |
| K060337 | SAUTER AG |
ZELGSTRASSE 8 | SULGEN TG | CH-8583 | |
| K033538 | SAUTER AG |
ZELGSTRASSE 8 | SULGEN TG | CH-8583 | |
| K021223 | SAUTER AG |
ZELGSTRASSE 8 | SULGEN | CH-8583 | |
| K021064 | SCICAN |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K962179 | SCICAN |
2002 SMALLMAN ST. | PITTSBURGH | PA | 15222 |
| K983679 | SCICAN |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K944036 | SCICAN |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K090265 | SCICAN LTD. |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K210326 | SciCan Ltd. |
1440 Don Mills Road | Toronto | M3B 3P9 | |
| K190062 | SciCan Ltd. |
1440 Don Mills Road | Toronto | M3B 3P9 | |
| K192910 | SciCan Ltd. |
1440 Don Mills Road | Toronto | M3B 3P9 | |
| K112872 | SCICAN LTD. |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K214057 | SciCan Ltd. |
1440 Don Mills Road | Toronto | M3B 3P9 | |
| K072466 | SCICAN LTD. |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K220102 | Shinva Medical Instrument Co., Ltd. |
Xinhua Medical Scientific Zone, Zibo New & Hi-Tech | Zibo | 255086 | |
| K213545 | Steelco S.P.A. |
Via Balegante, 27 | Riese Pio X | 31039 | |
| K232485 | Steris |
5960 Heisley Rd | Mentor | OH | 44060 |
| K212424 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K211500 | Steris Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K183410 | STERIS Corporation |
5960 Heisley Rd. | Mentor | OH | 44060 |
| K020747 | STERIS Corporation |
2424 WEST 23RD ST. | ERIE | PA | 16506 |
| K010865 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K030789 | STERIS Corporation |
2424 WEST 23RD ST. | ERIE | PA | 16506 |
| K112055 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K112403 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K111223 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K173493 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K173481 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K173485 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K082435 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K091731 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K173490 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K203061 | STERIS Corporation |
5960 Heisley Rd | Mentor | OH | 44060 |
| K091136 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K092490 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K000077 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K982332 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K980014 | STERIS Corporation |
2424 WEST 23RD ST. | ERIE | PA | 16506 |
| K962755 | STRYKER CORP. |
MEDICAL DIV. | KALAMAZOO | MI | 49001-6197 |
| K231489 | Sturdy Industrial Co., Ltd |
No. 168 Sec. 1, Zhongxing Road, Wugu District | New Taipei City | 24872 | |
| K181993 | Sturdy Industrial Co., Ltd |
No. 168 Sec. 1, Zhongxing Road, Wugu District | New Taipei City | 24872 | |
| K003470 | TUTTNAUER CO. LTD. |
1776 K ST. N.W. | WASHINGTON | DC | 20006-2365 |
| K111736 | TUTTNAUER CO. LTD. |
1700 K STREET NW | WASHINGTON | DC | 20006 |
| K063711 | TUTTNAUER CO. LTD. |
1776 K ST. N.W. | WASHINGTON | DC | 20006-2365 |
| K213080 | Tuttnauer Ltd. |
Har-Tuv Industrial Zone | Beit-Shemesh | 9910101 | |
| K221227 | Tuttnauer Ltd. |
Har-Tuv Industrial Zone | Beit-Shemesh | 9910101 | |
| K181456 | Tuttnauer Ltd. |
Har Tuv B Industrial Park | Beit Shemesh | ||
| K222608 | Tuttnauer LTD. |
Har-Tuv Industrial Zone | Beit-Shemesh | 9910101 | |
| K232658 | Tuttnauer U.S.A Co, Ltd |
25 Power Drive Hauppauge | New York | NY | 11788 |
| K032192 | TUTTNAUER USA CO. LTD. |
1776 K STREET, N.W. | WASHINGTON | DC | 20006-7910 |
| K143311 | TUTTNAUER USA CO. LTD. |
25 POWER DR. | HAUPPAUGE | NY | 11788 |
| K021504 | TUTTNAUER USA CO. LTD. |
1776 K STREET, N.W. | WASHINGTON | DC | 20006-7910 |
| K090783 | TUTTNAUER USA CO. LTD. |
1700 K STREET, NW | WASHINGTON | DC | 20006 |
| K993856 | TUTTNAUER USA CO. LTD. |
1776 K STREET, N.W. | WASHINGTON | DC | 20006-7910 |
| K962282 | TUTTNAUER USA CO. LTD. |
33 COMAC LOOP, EQUI-PARK | RONKONKOMA | NY | 11779 |
| K973550 | TUTTNAUER USA CO. LTD. |
1333 NEW HAMPSHIRE AVE., N.W. | WASHINGTON | DC | 20036 |
| K223858 | W&H Sterilization S.r.l. |
Via Bolgara, 2 | Brusaporto | 24060 | |
| K233504 | W&H Sterilization S.r.l. |
Via Bolgara, 2 | Brusaporto | 24060 | |
| K213758 | W&H Sterilization s.r.l. |
Via Bolgara, 2 | Brusaporto | 24060 | |
| K172825 | W&H Sterilization s.r.l. |
Via Bolgara, 2 | Brusaporto |
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