FDA 510(k) Applications for Medical Device:
Saline, Vascular Access Flush
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K111034 |
AM USA |
5209 LINDBAR DRIVE
| NASHVILLE |
TN |
37167 |
K113555 |
AM USA |
5209 LINDBAR DRIVE
| NASHVILLE |
TN |
37167 |
K213522 |
Amsino International, Inc. |
708 Corporate Center Drive
| Pomona |
CA |
91768 |
K183473 |
Amsino International, Inc. |
708 Corporate Center Drive
| Pomona |
CA |
91768 |
K120836 |
AMUSA |
5209 Linbar Dr Ste 640
| NASHVILLE |
TN |
37211 |
K133685 |
AMUSA |
5209 Linbar Dr Ste 640
| NASHVILLE |
TN |
37211 |
K230756 |
Anhui Tiankang Medical Technology Co., Ltd. |
No. 228 Weiyi Road, Economic Development Zone
| Tianchang |
|
|
K223584 |
Anhui Tianyang Pharmaceutical Co., Ltd. |
46 Tiantong Road, Tianchang City, Anhui Province
| Tianchang |
|
|
K042061 |
BECTON DICKINSON |
1 BECTON DR.
| FRANKLIN LAKES |
NJ |
07417-1880 |
K121050 |
BECTON DICKINSON & CO. |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K161552 |
Becton Dickinson and Company |
1 Becton Drive
| Franklin Lakes |
NJ |
07045 |
K153481 |
BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE
| FRANKLIN LAKES |
NJ |
07417 |
K141311 |
Becton, Dickinson and Company |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K231161 |
Becton, Dickinson and Company |
1 Becton Dr
| Franklin Lakes |
NJ |
07417 |
K082837 |
EXCELSIOR MEDICAL CORP. |
1933 HECK AVE.
| NEPTUNE |
NJ |
07753 |
K101270 |
EXCELSIOR MEDICAL CORP. |
4 INNOVATION DRIVE
| DUNDAS, ON |
|
L2H 7P3 |
K142620 |
Excelsior Medical Corporation |
1933 Heck Avenue
| Neptune |
NJ |
07553 |
K231363 |
Hantech Medical Device Co., Ltd. |
No 288 Sanheng Road, Changhe Industrial Park, Cixi
| Ningbo |
|
315326 |
K090882 |
HOSPIRA, INC. |
275 NORTH FIELD DR.
| LAKE FOREST |
IL |
60045 |
K121231 |
IND NDIAGNOSTIC INC. |
1629 FOSTERS WAY
| DELTA, BRITISH COLUMBIA |
|
V3M 6S7 |
K220060 |
Jiangsu Caina Medical Co., Ltd. |
No.23, Huanxi Rd, Zhutang Town
| Jiangyin |
|
214415 |
K020996 |
MEDEFIL, INC. |
492 LUNT AVE.
| SCHAUMBURG |
IL |
60193 |
K020999 |
MEDEFIL, INC. |
492 LUNT AVE.
| SCHAUMBURG |
IL |
60193 |
K091583 |
MEDEFIL, INC. |
250 WINDY POINT DR.
| GLENDALE HEIGHTS |
IL |
60139 |
K121262 |
MEDEFIL, INC. |
250 WINDY POINT DR.
| GLENDALE HEIGHTS |
IL |
60139 |
K173348 |
Medline Industries, Inc. |
Three Lakes Drive
| Northfield |
IL |
60093 |
K191378 |
Medline Industries, Inc. |
Three Lake Drive
| Northfield |
IL |
60093 |
K171109 |
MedXL Inc. |
285 Av Labrosse
| Pointe-Claire |
|
H9R 1A3 |
K192414 |
MedXL Inc. |
285 Av Labrosse
| Pointe-Claire |
|
H9R 1A3 |
K231754 |
MedXL Inc. |
285 Avenue Labrosse
| Pointe-Claire |
|
H9R 1A3 |
K150143 |
NURSE ASSIST, INC. |
4409 Haltom Rd
| Haltom City |
TX |
76117 |
K201286 |
Nurse Assist, LLC |
4409 Haltom Road
| Haltom City |
TX |
76117 |
K214080 |
PENTAFERTE ITALIA S.R.L. |
Viale Piane Nocella, 23
| Campli Teramo |
|
64012 |
K103740 |
SPECTRA MEDICAL DEVICES, INC. |
3000 K ST., NW
| WASHINGTON |
DC |
20007 |
K082689 |
SPECTRA MEDICAL DEVICES, INC. |
3000 K ST., NW
| WASHINGTON |
DC |
20007 |
K011283 |
THE KENDALL COMPANY |
15 HAMPSHIRE ST.
| MANSFIELD |
MA |
02048 |
K032438 |
TYCO HEALTHCARE |
15 HAMPSHIRE ST.
| MANSFIELD |
MA |
02048 |
K060339 |
TYCO HEALTHCARE/KENDALL |
15 HAMPSHIRE STREET
| MANSFIELD |
MA |
02048 |
|
|