FDA 510(k) Applications for Medical Device:
Light, Surgical, Ceiling Mounted
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131893 | AJW TECHNOLOGY CONSULTANTS, INC. |
445 APOLLO BEACH BLVD | APOLLO BEACH | FL | 33572 |
| K030906 | ALM |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623 |
| K040735 | ALM S.A. |
1777 EAST HENRIETTA ROAD | ROCHESTER | NY | 14623-3133 |
| K040015 | ALM S.A. |
1777 EAST HENRIETTA ROAD | ROCHESTER | NY | 14623-3133 |
| K982063 | ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. | ANAHEIM | CA | 92801-1009 |
| K090378 | BERCHTOLD GMBH & CO. KG |
1950 HANAHAN ROAD | CHARLESTON | SC | 29406 |
| K120392 | BERCHTOLD GMBH & CO. KG |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K965130 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K974433 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K990656 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K991527 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K083066 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STRABE 25 | TUTTLINGEN | D-78532 | |
| K080857 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STRABE 25 | TUTTLINGEN | D-78532 | |
| K024132 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K101537 | BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. | CHATSWORTH | CA | 91311 |
| K961843 | BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. | CHATSWORTH | CA | 91311 |
| K963682 | BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. | CHATSWORTH | CA | 91311 |
| K042395 | BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. | CHATSWORTH | CA | 91311 |
| K000639 | BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. | CHATSWORTH | CA | 91311 |
| K031979 | CONMED INTEGRATED SYSTEMS (CMIS) |
1815 NW 169TH PLACE | BEAVERTON | OR | 97006 |
| K132307 | CONVIDA HEALTHCARE & SYSTEMS CORPORATION |
2F AND B2, NO.33, DINGHU RD | TAOYUAN COUNTY | 33378 | |
| K140930 | CONVIDA HEALTHCARE & SYSTEMS CORPORATION |
NO. 33, DINGHU ROAD, GUISHAN TOWNSHIP | TAOYUAN COUNTY | 33378 | |
| K142076 | DICKSON & DICKSON HEALTHCARE (US), INC |
503 CANAL BLVD | RICHMOND | CA | 94804 |
| K140461 | DR. MACH GMBH & CO. KG |
FEHMARNSTRASSE 31 | NORDERSTEDT, SCHLESWIG-HOLSTEIN | 22846 | |
| K140460 | DR. MACH GMBH & CO. KG |
FEHMARNSTRASSE 31 | NORDERSTEDT, SCHLESWIG-HOLSTEIN | 22846 | |
| K093010 | DR. MACH GMBH & CO. KG |
FLOSSMANNSTRABE 28 | EBERSBERG | 85560 | |
| K093009 | DR. MACH GMBH & CO. KG |
FLOSSMANNSTRABE 28 | EBERSBERG | 85560 | |
| K984611 | DRAGER MEDIZINTECHNIK GMBH |
53/55 MOISLINGER ALLEE | LUEBECK | D-23542 | |
| K993242 | GETINGE/CASTLE, INC. |
7371 SPARTAN BLVD E. | NORTH CHARLESTON | SC | 29418 |
| K974084 | GETINGE/CASTLE, INC. |
7371 SPARTAN BLVD E. | NORTH CHARLESTON | SC | 29418 |
| K954169 | HERAEUS MED GMBH |
HERAEUSSTRASSE 12-14 | HANAU | D-63450 | |
| K973466 | HERAEUS MED GMBH |
HERAEUSSTRASSE 12-14 | HANAU | D-63450 | |
| K981081 | HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST | BATESVILLE | IN | 47006 |
| K100702 | HUOT INSTRUMENTS, LLC |
N50 W13740 OVERVIEW DR. | MENOMONEE FALLS | WI | 53051 |
| K070442 | MAQUET S.A. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14623 |
| K063333 | MAVIG GMBH |
STAHLGRUBERRING 5 | MUNCHEN | 81829 | |
| K042382 | MED-GENERAL TECHNOLOGIES LLC |
1016 COLLIER CENTER WAY | NAPLES | FL | 34110 |
| K140812 | MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST. | SAN FERNANDO | CA | 91340 |
| K083323 | NUVO, INC. |
5368 KUHL RD. | ERIE | PA | 16407 |
| K122875 | ORICARE, INC. |
1900 AM DRIVE | QUAKERTOWN | PA | 18951 |
| K071698 | SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST., S.E. | GRAND RAPIDS | MI | 49512 |
| K992090 | SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST., S.E. | GRAND RAPIDS | MI | 49512 |
| K002463 | SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST S.E. | GRAND RAPIDS | MI | 49588-8615 |
| K021585 | SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST., S.E. | GRAND RAPIDS | MI | 49512 |
| K072072 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K132747 | STRYKER COMMUNICATIONS |
1410 LAKESIDE PKWY., #100 | FLOWER MOUND | TX | 75028 |
| K060802 | STRYKER COMMUNICATIONS CORP. |
1410 LAKESIDE PKWY., #100 | FLOWER MOUND | TX | 75028 |
| K031068 | Stryker Endoscopy |
5900 OPTICAL CT. | SAN JOSE | CA | 95138 |
| K142984 | SUNNEX, INC. |
9319 FORSYTH PARK DRIVE | CHARLOTTE | NC | 28273 |
| K061317 | TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG |
BENZSTRASSE 26 | MUNCHEN | 82178 | |
| K102758 | TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG |
1046 LEGRAND BOULEVARD | CHARLESTON | SC | 29492 |
| K011693 | TRUMPF MEDICAL SYSTEMS, INC. |
415 JESSEN LN. | WANDO | SC | 29492 |
| K132551 | UMBEL CORPORATION |
2339 CANYON PARK DR. | DIAMOND BAR | CA | 91765 |
| K010716 | VAL MED CORP. |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004 |
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