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 | |
| K233623 | 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 |
| K231724 | SPM Medicare Pvt. Ltd. |
B-40, Phase II | Noida, Gautam Budh Nagar | 201305 | |
| 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 |
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