FDA 510(k) Applications for Medical Device:
Endoscopic Guidewire, Gastroenterology-Urology
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K072354 | ACCELLENT INC. |
100 FORDHAM ROAD | WILMINGTON | MA | 01887 |
| K141820 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K964780 | C.R. BARD, INC. |
129 CONCORD RD. | BILLERICA | MA | 01821-7031 |
| K962178 | C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 | BILLERICA | MA | 01821 |
| K131072 | COLOPLAST A/S |
1601 WEST RIVER ROAD N | MINNEAPOLIS | MN | 55411 |
| K150927 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K050304 | CONMED CORP. |
129 CONCORD ROAD | BILLERICA | MA | 01821 |
| K082536 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K023603 | ENDO-THERAPEUTICS, INC. |
1183 CEDAR ST. | SAFETY HARBOR | FL | 34695-2908 |
| K990765 | FLEXMEDICS |
12400 WHITEWATER DR. | MINNETONKA | MN | 55343 |
| K964955 | FLEXMEDICS |
12400 WHITEWATER DR. | MINNETONKA | MN | 55343 |
| K140482 | LAKE REGION MEDICAL |
340 LAKE HAZELTINE DRIVE | CHASKA | MN | 55318 |
| K080508 | LAKE REGION MEDICAL |
340 LAKE HAZELTINE DRIVE | CHASKA | MN | 55318 |
| K124052 | LAKE REGION MEDICAL |
340 LAKE HAZELTINE DRIVE | CHASKA | MN | 55318 |
| K142397 | Lake Region Medical |
340 Lake Hazeltine Dr. | Chaska | MN | 55318 |
| K081708 | LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. | CHASKA | MN | 55318 |
| K153264 | MEDI-GLOBE CORPORATION |
7850 SOUTH HARDY DRIVE | TEMPE | AZ | 85284 |
| K123439 | NEOMETRICS, INC. |
2605 FERNBROOK LANE N. | PLYMOUTH | MN | 55447 |
| K133076 | NEOMETRICS, INC. |
2605 FERNBROOK LANE N. | PLYMOUTH | MN | 55447 |
| K150225 | NEOMETRICS, INC. |
2605 FERNBROOK LANE N. | PLYMOUTH | MN | 55447 |
| K060034 | NIPRO MEDICAL CORPORATION |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514 |
| K021179 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K011759 | RADIUS MEDICAL TECHNOLOGIES, INC. |
63 GREAT RD. | MAYNARD | MA | 01754 |
| K053028 | TECHDEVICE CORPORATION |
650 PLEASANT ST. | WATERTOWN | MA | 02472 |
| K091417 | TERUMO CORP. |
950 Elkton Blvd. | Elkton | MD | 21921 |
| K971937 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K151471 | Terumo Medical Corporation |
265 Davidson Ave, Suite 320 | Somerset | NJ | 08873 |
| K122816 | WILSON-COOK MEDICAL INC. |
4900 Bethania Station Rd | Winston Salem | NC | 27105 |
| K142950 | Wilson-Cook Medical, Inc |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
| K033754 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K040137 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K113692 | XENOLITH MEDICAL |
1 LESHEM, | KITYAT-GAT | 82000 | |
| K123438 | XENOLITH MEDICAL |
Hahadas 9 PO Box 241 | Or Akiva | 3065201 |
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