FDA 510(k) Applications for Medical Device:
System, Monitoring, Perinatal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K030261 | ACCESS BATTERY, INC. |
5357 HIGHWAY 86 | ELIZABETH | CO | 80107 |
| K112159 | ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST | HIALEAH | FL | 33010 |
| K112187 | ADVANCED INSTRUMENTATIONS, INC. |
601 W 20 ST | HIALEAH | FL | 33010 |
| K141194 | ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 STREET | HIALEAH | FL | 33010 |
| K112317 | ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST | HIALEAH | FL | 33010 |
| K955931 | ADVANCED MEDICAL SYSTEMS, INC. |
925 SHERMAN AVE. | HAMDEN | CT | 06514 |
| K974248 | AIR-SHIELDS, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K090061 | AIRSTRIP TECHNOLOGIES, LP |
3303 OAKWELL CT., SUITE 200 | SAN ANTONIO | TX | 78218 |
| K090269 | AIRSTRIP TECHNOLOGIES, LP |
3303 OAKWELL CT., SUITE 200 | SAN ANTONIO | TX | 78218 |
| K173715 | AlertWatch, Inc. |
1600 Huron Parkway, Bldg. 520, Ste. 2326 | Ann Arbor | MI | 48109 |
| K971099 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K040819 | AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. | HANOVER | MD | 21076 |
| K983395 | ANALOGIC CORP. |
8 CENTENNIAL DR. | PEABODY | MA | 01960 |
| K002503 | ANALOGIC CORP. |
8 CENTENNIAL DR. | PEABODY | MA | 01960 |
| K011304 | ANALOGIC CORP. |
360 AUDUBON RD. | WAKEFIELD | MA | 01880 |
| K043598 | BIONET CO., LTD. |
MEDICAL INDUSTRY TECHNO TOWER | WONJU, KWANGWON-DO | ||
| K043597 | BIONET CO., LTD. |
MEDICAL INDUSTRY TECHNO TOWER | WONJU, KWANGWON-DO | ||
| K994008 | BIOSYS CO. LTD. |
16303 PANORAMIC WAY | SAN LEANDRO | CA | 94578 |
| K121267 | BISTOS CO., LTD. |
111 ELLISON STREET | PATERSON | NJ | 07505 |
| K103545 | BISTOS CO., LTD. |
4802 GLENWOOD ROAD | BROOKLYN | NY | 11234 |
| K100885 | BISTOS CO., LTD. |
111 ELLISON STREET | PATERSON | NJ | 07505 |
| K052190 | BISTOS CO., LTD. |
340 SHADY GROVE ROAD | FLINTVILLE | TN | 37335 |
| K142799 | Bistos Co., Ltd. |
27 New England Drive | Ramsey | NJ | 07446 |
| K222327 | Bloom Technologies NV |
Schiepse Bos 6 | Genk | 3600 | |
| K960553 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
3649 SEHORN DR. | MALIBU | CA | 90265 |
| K010552 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K021574 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K091251 | CERNER CORP. |
2800 ROCKCREEK PKWY. | KANSAS CITY | MO | 64117 |
| K121758 | CERNER CORP. |
10234 MARION PARK DRIVE | KANSAS CITY | MO | 64137 |
| K050826 | CETRO AMERICA |
925 SHERMAN AVENUE | HAMDEN | CT | 06514 |
| K051175 | CIVENT COMMUNICATIONS LTD |
MESHEK 58 | MOSHAV HEMED | 50295 | |
| K103172 | CIVNET COMMUNICATION LTD |
Hatamar 58 | Moshav Hemed | 50295 | |
| K121208 | CLINICAL COMPUTER SYSTEMS, INC. |
715 TOLLGATE RD. | ELGIN | IL | 60123-9331 |
| K050234 | E.CARE SOLUTIONS, INC. |
6740 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K143695 | EDAN INSTRUMENTS INC |
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK | SHENZHEN | 518067 | |
| K173042 | Edan Instruments, Inc |
#15 Jinhui Road, Jinsha Community | Shenzhen | 518122 | |
| K073221 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K082369 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K040903 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K171178 | Edan Instruments, Inc. |
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District | Shenzhen | 518122 | |
| K100358 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K082602 | EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA | YONKERS | NY | 10701 |
| K150901 | EDAN INSTRUMENTS, INC. |
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI ROAD #1019 | SHENZHEN | 518067 | |
| K100797 | EDAN INSTRUMENTS, INC. |
55 Northern Blvd | Great Neck | NY | 11021 |
| K102140 | EDAN INSTRUMENTS, INC. |
NANHAI ROAD 1019#, SHEKOU, | SHENZHEN, GUANGDONG | ||
| K171865 | Farus, LLC |
1240 Keystone Way | Vista | CA | 92081 |
| K072976 | GE HEALTHCARE |
8880 GORMAN RD | LAUREL | MD | 20723 |
| K111614 | GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY | BARRINGTON | IL | 60010 |
| K964770 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K955559 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K993751 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K032252 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4502 WOODLAND CORPORATE BLVD. | TAMPA | FL | 33614 |
| K021135 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K050583 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4502 WOODLAND CORPORATE BLVD. | TAMPA | FL | 33614 |
| K012718 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K220732 | GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive | Wauwatosa | WI | 53226 |
| K991739 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
200 HARRY SOUTH TRUMAN PKWY. | ANNAPOLIS | MD | 21401 |
| K991905 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
61 BARNES PARK RD. NORTH | WALLINGFORD | CT | 06492-0333 |
| K131941 | GUANGDONG BIOLIGHT MEDITECH CO., LTD |
P.O. BOX 120-119 | SHANGHAI | 200237 | |
| K153580 | GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
NO. 2 INNOVATION FIRST ROAD | ZHUHAI | 519085 | |
| K970456 | HEWLETT-PACKARD GMBH |
SCHICKARD STRASSE 4 | WUERTTEMBERG | 71034 | |
| K954351 | HEWLETT-PACKARD GMBH |
SCHICKARD STRASSE 4 | WUERTTEMBERG | 71034 | |
| K014094 | HILL-ROM MANUFACTURING, INC. |
11000 REGENCY PKWY. | CARY | NC | 27511 |
| K032772 | HILL-ROM MANUFACTURING, INC. |
1225 CRESCENT GREEN | CARY | NC | 27511 |
| K080226 | HILL-ROM MANUFACTURING, INC. |
1225 CRESCENT GREEN DR. | CARY | NC | 27511 |
| K001677 | HUNTLEIGH DIAGNOSTICS LTD. |
35 PORTMANMOOR ROAD | CARDIFF WALES | CF2 2HB | |
| K002548 | HUNTLEIGH DIAGNOSTICS LTD. |
35 PORTMANMOOR ROAD | CARDIFF WALES | CF2 2HB | |
| K132650 | HUNTLEIGH HEALTHCARE LIMITED |
35 PORTMANMOOR ROAD | CARDIFF, WALES | CF24 5HN | |
| K200975 | Huntleigh Healthcare Limited |
35 Portmanmoor Road | Cardiff | CF24 5HN | |
| K060230 | HUNTLEIGH HEALTHCARE LTD. |
35 PORTMANMOOR RD. | CARDIFF, SOUTH GLAMORGAN | CF24 5HN | |
| K090285 | HUNTLEIGH HEALTHCARE LTD. |
35 PORTMANMOOR RD. | CARDIFF, SOUTH WALES | CF24 5HN | |
| K963711 | HUNTLEIGH HEALTHCARE, INC. |
227 RT. 33 EAST | MANALAPAN | NJ | 07726 |
| K010889 | HUNTLEIGH HEALTHCARE, INC. |
35 PORTMANMOOR ROAD | CARDIFF | CF24 5HN | |
| K010894 | HUNTLEIGH HEALTHCARE, INC. |
35 PORTMANMOOR ROAD | CARDIFF | CF24 5HN | |
| K990569 | HUNTLEIGH HEALTHCARE, INC. |
227 RT. 33 EAST | MANALAPAN | NJ | 07726 |
| K001882 | HUNTLEIGH HEALTHCARE, INC. |
40 CHRISTOPHER WAY | EATONTOWN | NJ | 07724-3327 |
| K052715 | LMS MEDICAL SYSTEMS (CANADA), LTD. |
5252 DE MAISONNEUVE WEST, #314 | MONTREAL, QC | H4A 3S5 | |
| K980719 | LMS MEDICAL SYSTEMS LTD. |
5252 DE MAISONNEUVE WEST, #314 | MONTREAL, QC | H4A 3S5 | |
| K040788 | LMS MEDICAL SYSTEMS LTD. |
5252 DE MAISONNEUVE WEST, #314 | MONTREAL, QC | H4A 3S5 | |
| K993008 | MARQUETTE MEDICAL SYSTEMS, INC. |
200 HARRY SOUTH TRUMAN PKWY. | ANNAPOLIS | MD | 21401 |
| K102263 | MCKESSON INFORMATION SOLUTIONS LLC |
1835 MARKET ST. 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K110612 | MEDIANA CO., LTD. |
WONJU MEDICAL IND. PARK | WONJU-SI, GANGWON-DO | 220-801 | |
| K161902 | MINDCHILD MEDICAL |
1600 OSGOOD STREET #2-17 | NORTH ANDOVER | MA | 01845 |
| K120018 | MINDCHILD MEDICAL |
755 WESTMINSTER STREET | PROVIDENCE | RI | 02903 |
| K142883 | Mindchild Medical |
1600 Osgood Street #2-17 | North Andover | MA | 01845 |
| K042082 | MP4 SOLUTIONS, LP |
11 LYNN BATTS LANE | SAN ANTONIO | TX | 78218 |
| K013281 | NICOLET BIOMEDICAL |
6355 JOYCE DR. | GOLDEN | CO | 80403 |
| K150398 | OB TOOLS, LTD. |
MIFALEY HAEMEK INDUSTRIAL ZONE | MIGDAL HA-EMEK | 2310502 | |
| K002150 | OXFORD INSTRUMENTS |
MANOR WAY | OLD WOKING, SURREY | GU22 9JU | |
| K023618 | OXFORD INSTRUMENTS MEDICAL LTD. |
MANOR WAY | OLD WOKING, SURREY | GU22 9JU | |
| K992607 | OXFORD INSTRUMENTS MEDICAL SYSTEMS |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K023931 | PHILIPS MEDICAL SYSTEMS, INC. |
NEDERLAND B.V. | DA BEST | 5680 | |
| K140535 | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
HEWLETT-PACKARD-STR. 2 | BOBLINGEN | D-71034 | |
| K102958 | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
HEWLETT-PACKARD-STR. 2 | BOBLINGEN | 71034 | |
| K173941 | Philips Medizin Systeme Boeblingen GmbH |
Hewlett-Packard-Str.-2 | Boeblingen | 71034 | |
| K081203 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BADEN-WUERTTEMBERG | D-71034 | |
| K092028 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BOEBLINGEN | D-71034 | |
| K100420 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BOEBLINGEN | 71034 | |
| K062137 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 | BOEBLINGEN, BADEN-WTTBG | D 71034 | |
| K052795 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K071800 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN, BADEN-WUERTTEMBERG | D 71034 | |
| K111083 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K960109 | QUANTITATIVE MEDICINE, INC. |
200 HARRY S. TRUMAN PKWY. | ANNAPOLIS | MD | 21401 |
| K963608 | QUANTITATIVE MEDICINE, INC. |
61 BARNES PARK RD. NORTH | WALLINGFORD | CT | 06492 |
| K132918 | SENSE4BABY, INC. |
3344 N. TORREY PINES COURT, STE 100 | LA JOLLA | CA | 92037 |
| K965008 | SPACELABS MEDICAL, INC. |
925 SHERMAN AVE. | HAMDEN | CT | 06514 |
| K123335 | SUNRAY MEDICAL APPARATUS CO., LTD. |
B102 NANSHAN MEDICAL DEVICES | SHENZHEN, GUANGDONG | 518067 | |
| K043075 | TENACORE HOLDINGS, INC. |
647 EAST YOUNG STREET | SANTA ANA | CA | 92705 |
| K110556 | WIPRO GE HEALTHCARE PRIVATE, LTD. |
8880 GOMAN ROAD | LAUREL | MD | 20723-5800 |
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