FDA 510(k) Applications for Medical Device:
Marker, Radiographic, Implantable
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K121964 | AUGMENIX , INC. |
204 SECOND AVENUE | WALTHAM | MA | 02451 |
| K151998 | AUGMENIX, INC. |
204 SECOND AVENUE, LOWER LEVEL | WALTHAM | MA | 02451 |
| K180061 | Bard Peripheral Vascular, Inc. |
1625 W. 3rd Street | Tempe | AZ | 85281 |
| K152510 | BARD PERIPHERAL VASCULAR, INC. |
1625 WEST 3RD STREET | TEMPE | AZ | 85281 |
| K012955 | BIOFORM, INC. |
4133 COURTNEY ROAD, #10 | FRANKSVILLE | WI | 53126 |
| K010348 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K023694 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K090501 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K130537 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K121113 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | FL | 33760 |
| K083006 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K060769 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K133697 | BREAST-MED, INC. |
1745 BRIDGEWATER ROAD | GOLDEN VALLEY | MN | 55422 |
| K123911 | C.R. BARD, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281-1740 |
| K090547 | C.R. BARD, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281-2438 |
| K192771 | C4 Imaging LLC |
196 West Ashland Street | Doylestown | PA | 18901 |
| K132708 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K070436 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K042296 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K063193 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K100994 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K141722 | CAREFUSION |
75 NORTH FAIRWAY DRIVE | VERNON HILLS | IL | 60061 |
| K132463 | CIANNA MEDICAL, INC. |
6 JOURNEY | ALISO VIEJO | CA | 92656 |
| K171767 | Cianna Medical, Inc. |
6 Journey, Suite 125 | Aliso Viejo | CA | 92656 |
| K181007 | Cianna Medical, Inc. |
6 Journey, Suite 125 | Aliso Viejo | CA | 92656 |
| K102506 | CORTEX MANUFACTURING, INC. |
421 S. DAVIES RD. | LAKE STEVENS | WA | 98258 |
| K152586 | Covidien LLC |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K142198 | Covidien LLC |
2000 Commonwealth Ave Suite 110 | Auburndale | MA | 02466 |
| K072219 | CYTOPHIL INC |
5546 N SANTA MONICA BLVD | WHITEFISH BAY | WI | 53217-5159 |
| K203097 | Devicor Medical Products, Inc |
300 E-Business Way, Fifth Floor | Cincinnati | OH | 45241 |
| K161021 | DEVICOR MEDICAL PRODUCTS, INC. |
300 E-BUSINESS WAY, | Cincinnati | OH | 45241 |
| K210752 | Devicor Medical Products, Inc. |
300 E-Business Way, Fifth Floor | Cincinnati | OH | 45241 |
| K212158 | Devicor Medical Products, Inc. |
300 E-Business Way, Fifth Floor | Cincinnati | OH | 45241 |
| K170803 | Devicor Medical Products, Inc. |
300 E-Business Way, Fifth Floor | Cincinnati | OH | 45241 |
| K221961 | Devicor Medical Products, Inc. |
300 E-Business Way, Fifth Floor | Cincinnati | OH | 45241 |
| K183400 | Elucent Medical, Inc |
7480 Flying Cloud Drive, Suite 110 | Eden Prairie | MN | 55344 |
| K180640 | Elucent Medical, Inc. |
7480 Flying Cloud Drive, Suite 101 | Eden Prairie | MN | 55344 |
| K011856 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K222832 | Endomagnetics Ltd |
330 Cambridge Science Park, Milton Road | Cambridge | CB4 0WN | |
| K173587 | Endomagnetics Ltd. |
The Jeffreys Building, Cowley Road | Cambridge | CB4 0WS | |
| K082278 | ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD. | CINCINNATI | OH | 45242 |
| K020276 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K013413 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K152070 | FOCAL THERAPEUTICS |
4370 Alpine Rd. #101 | Portola Valley | CA | 94028 |
| K143484 | FOCAL THERAPEUTICS |
4370 ALPINE RD. #101 | PORTOLA VALLEY | CA | 94028 |
| K192371 | Focal Therapeutics |
1010 Stewart Drive | Sunnyvale | CA | 94085 |
| K113202 | FOCAL THERAPEUTICS |
4370 ALPINE RD. #101 | PORTOLA VALLEY | CA | 94028 |
| K103417 | HALIFAX BIOMEDICAL, INC. |
3 ELIZABETH PLACE | LAKE HOPATCONG | NJ | 07849 |
| K090581 | HALIFAX BIOMEDICAL, INC. |
4 INNOVATION DR. | DUNDAS, ONTARIO | L9H 7P3 | |
| K181692 | Health Beacons, Inc. |
34 Walden St., #753 | Concord | MA | 01742 |
| K190932 | Health Beacons, Inc. |
34 Walden St. #753 | Concord | MA | 01742 |
| K193189 | Health Beacons, Inc. |
34 Walden St. #753 | Concord | MA | 01742 |
| K102768 | HOLOGIC, INC. |
6100 TECHNOLOGY CENTER DRIVE | INDIANAPOLIS | IN | 46278 |
| K042341 | INRAD |
4375 DONKER COURT S.E. | KENTWOOD | MI | 49512 |
| K063238 | INRAD |
4375 DONKER COURT S.E. | KENTWOOD | MI | 49512 |
| K183503 | INRAD Inc. |
4375 Donker Court SE | Kentwood | MI | 49512 |
| K072216 | KAPP SURGICAL INSTRUMENT, INC. |
4919 WARRENSVILLE CENTER RD. | CLEVELAND | OH | 44128 |
| K050384 | KAPP SURGICAL INSTRUMENT, INC. |
4919 WARRENSVILLE CENTER RD. | CLEVELAND | OH | 44128 |
| K093473 | KENT MEDICAL DEVICES, INC. |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K051421 | MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVENUE | GAINESVILLE | FL | 32608 |
| K053518 | MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVE. | GAINESVILLE | FL | 32608 |
| K212882 | Merit Medical Systems, Inc. |
1600 W Merit Parkway | South Jordan | UT | 84095 |
| K223107 | MOLLI Surgical, Inc |
50 Wellington Street East | Toronto | M5E 1C8 | |
| K210600 | MOLLI Surgical, Inc. |
22 St. Clair Ave. East, Suite #1500 | Toronto | M4t 2s3 | |
| K033447 | MRI DEVICES CORP. |
1515 PARAMOUNT DR. | WAUKESHA | WI | 53186 |
| K023450 | PROMEX, INC. |
3049 HUDSON ST. | FRANKLIN | IN | 46131 |
| K130763 | SCION MEDICAL TECHNOLOGIES LLC |
23879 BLUE SPRUCE RD | SAUK CENTRE | MN | 56378 |
| K140835 | SCION MEDICAL TECHNOLOGIES LLC |
90 Oak St | Newton | MA | 02464 |
| K153189 | SCION MEDICAL TECHNOLOGIES, LLC |
4613 WEST CHESTER PIKE | NEWTOWN SQUARE | PA | 19073 |
| K170905 | Scion Medical Technologies, LLC |
4613 West Chester Pike | Newtown Square | PA | 19073 |
| K031938 | SENORX, INC. |
11 COLUMBIA, SUITE A | ALISO VIEJO | CA | 92656 |
| K040706 | SENORX, INC. |
11 COLUMBIA, SUITE A | ALISO VIEJO | CA | 92656 |
| K080698 | SENORX, INC. |
11 COLUMBIA | ALISO VIEJO | CA | 92656 |
| K050090 | SENORX, INC. |
11 COLUMBIA, SUITE A | ALISO VIEJO | CA | 92656 |
| K081170 | SENORX, INC. |
11 COLUMBIA | ALISO VIEJO | CA | 92656 |
| K081085 | SENORX, INC. |
11 COLUMBIA | ALISO VIEJO | CA | 92656 |
| K131654 | SENORX, INC. |
1625 West 3rd Street | Tempe | AZ | 85281 |
| K111692 | SOMATEX MEDICAL TECHNOLOGIES GMBH |
UNTERER WINKEL 3 | WURMLINGEN | 78573 | |
| K182082 | Somatex Medical Technologies GmbH |
Rheinstrasse 7d | Teltow | 14513 | |
| K093064 | SOMATEX MEDICAL TECHNOLOGIES GMBH |
1480 CAMBRIDGE STREET | CAMBRIDGE | MA | 02139 |
| K073095 | SOMATEX MEDICAL TECHNOLOGIES GMBH |
1480 CAMBRIDGE STREET | CAMBRIDGE | MA | 02139 |
| K180443 | SOMATEX Medical Technologies GmbH |
Rheinstr. 7d | Teltow | 14513 | |
| K201863 | SOMATEX Medical Technologies GmbH |
Hohenzollerndamm 150/151 | Berlin | 14199 | |
| K180621 | Sonavex, Inc. |
2835 O'Donnell Street, Suite 200 | Baltimore | MD | 21224 |
| K072913 | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY |
6100 TECHNOLOGY CENTER DR. | INDIANAPOLIS | IN | 46278 |
| K102608 | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY |
6100 TECHNOLOGY CENTER DR. | INDIANAPOLIS | IN | 46278 |
| K062528 | SUROS SURGICAL SYSTEMS, INC. |
6100 TECHNOLOGY CENTER DR. | INDIANAPOLIS | IN | 46278 |
| K190689 | View Point Medical, Inc. |
5621 Palmer Way, Suite F | Carlsbad | CA | 92010 |
| K170026 | Viscus Biologics, LLC |
10000 Cedar Ave | Cleveland | OH | 44106 |
| K040990 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K014148 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K141356 | WILSON-COOK MEDICAL INC. |
4900 Bethania Station Rd | Winston Salem | NC | 27105 |
| K111895 | WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY |
4900 BETHANIA STATION ROAD | WINSTON-SALEM | NC | 27105 |
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