FDA 510(k) Applications for Medical Device:
Cable, Transducer And Electrode, Patient, (Including Connector)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093657 | ACIST MEDICAL SYSTEMS, INC. |
7905 FULLER ROAD | EDEN PRAIRIE | MN | 55344 |
| K992524 | ADVANTAGE MEDICAL ELECTRONICS, INC. |
10630 WILES RD. | CORAL SPRINGS | FL | 33076 |
| K980806 | AFFINITY MEDICAL TECHNOLOGIES, LLC. |
17332 VON KARMAN AVE., #115 | IRVINE | CA | 92614 |
| K070232 | AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. | HARMANS | MD | 21077 |
| K170536 | APK Technology Co., Ltd. |
6Floor, B2 Building, Industry of Hengfeng | Shenzhen | 518126 | |
| K200674 | Atrility Medical, LLC |
313 Price Place, Suite 13 | Madison | WI | 53705 |
| K181089 | Authentic Medical |
4470 Yankee Hill Rd., Ste 100 | Rocklin | CA | 95677 |
| K023334 | BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 33 | MISSISSAUGA, ONTARIO | L4W-4T7 | |
| K230571 | Baylis Medical Technologies Inc. |
2645 Matheson Blvd. East | Mississauga | L4W 5S4 | |
| K222370 | Beijing Rongrui-Century Science & Technology Co., Ltd. |
3rd Floor, West zone, No.1 Building, No.7 Yard, | Beijing | 100094 | |
| K001390 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K132253 | BOSTON SCIENTIFIC |
4100 HAMLINE AVE | ARDEN HILLS | MN | 55112 |
| K172591 | Boston Scientific Corporation |
4100 Hamline Avenue North | St. Paul | MN | 55112 |
| K013598 | C.R. BARD, INC. |
55 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K162432 | CAREFUSION 2200 INC. |
75 NORTH FAIRWAY DRIVE | VERNON HILLS | IL | 60061 |
| K163316 | CAREFUSION 303, INC. |
75 N Fairway Drive | Vernon Hills | IL | 60061 |
| K022075 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K081762 | CURBELL ELECTRONICS INC. |
5401 S. COTTONWOOD CT. | GREENWOOD VILLAGE | CO | 80121 |
| K080605 | CURBELL ELECTRONICS INC. |
20 CENTRE DR. | ORCHARD PARK | NY | 14127 |
| K182220 | Curbell Medical Products, Inc. |
20 Centre Drive | Orchard Park | NY | 14127 |
| K043572 | DATEX-OHMEDA |
86 PILGRIM RD. | NEEDHAM | MA | 02492 |
| K211941 | Energetic Designs, Inc. |
3037 Grizzly Peak Dr. | Broomfield | CO | 80023 |
| K080621 | EUROPEAN CUSTOM MANUFACTURING BV |
220 RIVER ROAD | CLAREMONT | NH | 03743 |
| K984263 | EWC |
N26W23315 PAUL RD. | PEWAUKEE | WI | 53072-4061 |
| K982817 | EWC |
N26W23315 PAUL RD. | PEWAUKEE | WI | 53072-4061 |
| K082851 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
9900 INNOVATION DR. | WAUWATOSA | WI | 53226 |
| K162768 | INTEGRAL PROCESS SAS |
12 RUE DES CAYENNES | CONFLANS SAINTE HONORINE | 78703 | |
| K203635 | JKH USA, LLC |
20505 Valley Blvd. Suite 108 | Walnut | CA | 91789 |
| K101660 | KEPLER MEDTEC |
200 Homer Ave | Ashland | MA | 01721 |
| K071751 | LIFESYNC CORPORATION |
8282 SHADOWWOOD DRIVE | CORAL SPRINGS | FL | 33071 |
| K980582 | MARQUETTE MEDICAL SYSTEMS, INC. |
100 MARQUETTE DR. | JUPITER | FL | 33468 |
| K080112 | MED-DYNE |
2775 SOUTH FLOYD ST. | LOUISVILLE | KY | 40209 |
| K002781 | MEDICAL CABLES, INC. |
1340 LOGAN AVE. | COSTA MESA | CA | 92626 |
| K181726 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K203556 | Medtronic , Inc. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K960446 | MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE | MINNEAPOLIS | MN | 55432-3576 |
| K954900 | MINNESOTA MINING AND MFG. CO. |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K182327 | Orantech Inc. |
Zone#A, 4F, 1st Bld, 7th Industrial Zone | Shenzhen | 518106 | |
| K012392 | PACE MEDICAL |
391 TOTTEN POND RD. | WALTHAM | MA | 02451 |
| K110287 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K200722 | QT Medical, Inc. |
1360 Valley Vista Dr., Suite 203 | Diamond Bar | CA | 91765 |
| K971968 | REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT | ALPHARETTA | GA | 30202 |
| K010809 | RF INDUSTRIES, LTD. |
541-A BIRCH ST. | LAKE ELSINORE | CA | 92530 |
| K153188 | SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. |
ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, | SHENZHEN | 518021 | |
| K200026 | Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park, | Longgang District, Shenzhen | 518000 | |
| K191428 | Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park | Longgang District, Shenzhen | ||
| K172797 | Shenzhen Coreray Technology., Ltd |
ChuangYe Technology Park,1th Dong Huan Road, | Shenzhen | 518109 | |
| K192404 | Shenzhen Coreray Technology., Ltd |
305, 307 Liangji Building, 1st Donghuan Road | Shenzhen | 518109 | |
| K120010 | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
INDUSTRIAL HUA WANG | SHENZHEN, GUANGDONG | 518109 | |
| K220447 | Shenzhen Med-link Electronics Tech Co., Ltd. |
4th and 5th Floor, Building Two, Hualian Industrial Zone, | Shenzhen | 518109 | |
| K093858 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
15900 VALLEY VIEW CT. | SYLMAR | CA | 91342 |
| K152947 | TIGER MEDICAL PRODUCTS |
JAJE PLAZA, SUITE 703, 1717 NORTH SICHUAN ROAD | Shanghai | 200080 | |
| K952659 | TRONOMED, INC. |
32921 CALLE PERFECTO | SAN JUAN CAPISTRANO | CA | 92675 |
| K102430 | TYCO ELECTRONICS CORPORATION |
10025 SW FREEMAN CT. | WILSONVILLE | OR | 97070 |
| K062577 | TZ MEDICAL, INC. |
7272 S.W. DURHAM RD., #800 | PORTLAND | OR | 97224 |
| K082959 | UNIMED MEDICAL SUPPLIES INC. |
NO.37, YANSHAN ROAD, SHEKOU | SHENZHEN, GUANGDONG | 518067 | |
| K142489 | UNIMED MEDICAL SUPPLIES INC. |
NO.37, YANSHAN ROAD, SHEKOU | SHENZHEN | 518067 | |
| K030005 | VANGUARD MEDICAL CONCEPTS, INC. |
5307 GREAT OAK DR. | LAKELAND | FL | 33815 |
| K190078 | Volcano Corporation |
3721 Valley Ctrre Dr Ste 500 | San Diego | CA | 92130 |
| K191273 | Vyaire Medical, Inc. |
26125 N. Riverwoods Blvd. | Mettawa | IL | 60630 |
| K211294 | Vyaire Medical, Inc. |
26125 North Riverwoods Blvd. | Mettawa | IL | 60045 |
| K200510 | Vyaire Medical, Inc. |
26125 N. Riverwoods Blvd. | Mettawa | IL | 60045 |
| K201359 | Xinkang Medical Instrument Co., Ltd |
2 Floor, Puhua Science and Technology Park, Tongsheng | Shenzhen | 518109 |
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