FDA 510(k) Applications for Medical Device:
Tubes, Vials, Systems, Serum Separators, Blood Collection
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K062932 | AHLSTROM MOUNT HOLLY SPRINGS LLC |
122 WEST BUTLER ST. | MOUNT HOLLY SPRINGS | PA | 17007 |
| K030815 | AKERS LABORATORIES, INC. |
201 GROVE RD. | THOROFARE | NJ | 08086 |
| K964698 | ANDWIN SCIENTIFIC |
1219 EAST BRIDLETRAIL RD. | DRAPER | UT | 84020-8523 |
| K223323 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
No. 2 Guanyin Road, Economic Development Zone, Taihu | Anqing City | 246400 | |
| K222141 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
No. 2 Guanyin Road, Economic Development Zone, Taihu | Anqing | 246400 | |
| K220900 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
No.2 Guanyin Road, Taihu Economic Development Zone, | Anqing | 246400 | |
| K202188 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
No. 2 Guanyin Road, Economic Development Zone | Taihu, Anqing City | 246400 | |
| K220258 | AVIA Vascular |
6030 W Harold Gatty Dr. | Salt Lake City | UT | 84116 |
| K965202 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K980414 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K991551 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K023075 | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
1 BECTON DRIVE, MCC 300 | FRANKLIN LAKES | NJ | 07417-1885 |
| K030573 | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
1 BECTON DR., BECTON BLDG. | FRANKLIN LAKES | NJ | 07417-1885 |
| K093972 | BECTON DICKINSON & CO. |
1 BECTON DRIVE, MC 300 | FRANKLIN LAKES | NJ | 07417-1880 |
| K022426 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K022130 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K101502 | BECTON DICKINSON & CO. |
1 BECTON DRIVE, MC300 | FRANKLIN LAKES | NJ | 07417-1885 |
| K013971 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K023331 | BECTON DICKINSON & CO. |
1 BECTON DRIVE, MC 300 | FRANKLIN LAKES | NJ | 07417-1880 |
| K041071 | BECTON DICKINSON & CO. |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K022875 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K222478 | Becton Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K213953 | Becton Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K091292 | BECTON DICKINSON AND COMPANY (BD) |
1 BECTON DRIVE. MC300 | FRANKLIN LAKES | NJ | 07417-1885 |
| K230865 | Becton Dickinson Infusion Therapy Systems, Inc. |
9450 S State St | Sandy | UT | 84070 |
| K991702 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K002456 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K982922 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K991120 | BECTON DICKINSON VACUTAINER SYSTEMS |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K991088 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K960250 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K980098 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K981013 | BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K220212 | Becton, Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K160657 | BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE | FRANKLIN LAKES | NJ | 07417 |
| K153309 | BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE | FRANKLIN LAKES | NJ | 07417 |
| K212724 | Becton, Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K202446 | Becton, Dickinson, and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K133303 | BIO-ANALYSIS, INC. |
27735 TAMARA DRIVE | YORBA LINDA | CA | 92887 |
| K090737 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR | HERCULES | CA | 94547 |
| K030394 | BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING |
6075 POPLAR AVE. | MEMPHIS | TN | 38119 |
| K030076 | BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING |
6075 POPLAR AVE. | MEMPHIS | TN | 38119 |
| K012221 | BIOSAFE LABORATORIES, INC. |
100 FIELD DRIVE #240 | LAKE FOREST | IL | 60045 |
| K201009 | CHIRANA T. Injecta |
Nαm. Dr. Schweitzera 194 | Starα Turα | 916 01 | |
| K213690 | Eclipse Medcorp LLC |
5916 Stone Creek Drive Suite #120 | The Colony | TX | 75056 |
| K971220 | GREINER AMERICA, INC. |
P.O. BOX 953279 | LAKE MARY | FL | 32795-3279 |
| K971236 | GREINER AMERICA, INC. |
P.O. BOX 953279 | LAKE MARY | FL | 32795-3279 |
| K971239 | GREINER AMERICA, INC. |
P.O. BOX 953279 | LAKE MARY | FL | 32795-3279 |
| K960860 | GREINER AMERICA, INC. |
7 HENRY CT. | WILMINGTON | DE | 19808 |
| K960857 | GREINER AMERICA, INC. |
7 HENRY CT. | WILMINGTON | DE | 19808 |
| K960858 | GREINER AMERICA, INC. |
7 HENRY CT. | WILMINGTON | DE | 19808 |
| K182078 | Greiner Bio-One NA Inc. |
4238 Capital Drive | Monroe | NC | 28110 |
| K122687 | GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 | BALDWIN | MD | 21013 |
| K063357 | GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 | BALDWIN | MD | 21013 |
| K081929 | GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 | BALDWIN | MD | 21013 |
| K103041 | GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 | BALDWIN | MD | 21013 |
| K011699 | GREINER BIO-ONE VACUETTE NORTH AMERICA |
PO BOX 103 | BALDWIN | MD | 21013 |
| K023971 | GREINER BIO-ONE VACUETTE NORTH AMERICA |
PO BOX 103 | BALDWIN | MD | 21013 |
| K992244 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K982999 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K991843 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K982998 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K983952 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K974873 | GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A | BEL AIR | MD | 21014 |
| K002777 | GREINER VACUETTE NORTH AMERICA, INC. |
P.O. BOX 6581 | ELLICOTT CITY | MD | 21042-0581 |
| K093910 | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
SUITE D NO.19, LANE 999 | SHANGHAI | 20030 | |
| K063852 | HOME ACCESS HEALTH CORP. |
2401 W. HASSELL | HOFFMAN ESTATES | IL | 60195-5200 |
| K061979 | IMMUNETECH CORPORATION |
888 OAK GROVE, SUITE 4 | MENLO PARK | CA | 94025 |
| K021698 | IMMUNETECH CORPORATION |
P.O. BOX 9433 | RANCHO SANTA FE | CA | 92067 |
| K030596 | IMMUNICON CORP. |
3401 MASONS MILL RD. STE 100 | HUNTINGDON VALLEY | PA | 19006-3574 |
| K123987 | INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
15059 CEDAR ST. | LEAWOOD | KS | 66224 |
| K220458 | Innovative Medical Technologies, Inc. |
14315 C Circle | Omaha | NE | 68144 |
| K000777 | ITL CORPORATION, PTY LTD. |
15825 SHADY GROVE RD. | ROCKVILLE | MD | 20850 |
| K021941 | ITL CORPORATION, PTY LTD. |
41-45 TENNANT ST. | FYSHWICK, CANBERRA ACT | 2609 | |
| K200027 | Jiangsu Caina Medical Co., Ltd. |
No.23, Huanxi Road, Zhutang Town | Jiangyin | 214415 | |
| K222834 | Jiangsu Caina Medical Co.,Ltd |
No.23, Huanxi Rd, Zhutang Town | Jiangyin | 214415 | |
| K212019 | Jiangsu Micsafe Medical Technology Co., Ltd |
Xituan Industrial Park, Dafeng District | Yancheng | 224125 | |
| K190485 | Kawasumi Laboratories, Inc. |
Shinagawa Intercity Tower B, 9th Floor | Tokyo | 108-6109 | |
| K191832 | Kurin, Inc |
10840 Thornmint Road, Suite 111 | San Diego | CA | 92127 |
| K181895 | Kurin, Inc |
10840 Thornmint Road, Suite 111 | San Diego | CA | 92127 |
| K220677 | Kurin, Inc, |
10840 Thornmint Road, Suite 111 | San Diego | CA | 920127 |
| K222299 | Magnolia Medical Technologies |
200 West Mercer Street, Suite 500 | Seattle | WA | 98119 |
| K192247 | Magnolia Medical Technologies, Inc. |
200 West Mercer Street | Seattle | WA | 98119 |
| K120490 | NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. | MIAMI | FL | 33172 |
| K193074 | NSP Tech Pte Ltd |
10 Admiralty Street, Northlink Building, #02-06 | Singapore | 757695 | |
| K181754 | NSP Tech Pte Ltd |
45A Macpherson Road | Singapore | 348470 | |
| K181743 | NSP Tech Pte Ltd |
45A Macpherson Road | Singapore | 348470 | |
| K974374 | OHMEDA MEDICAL |
100 MOUNTAIN AVE. | MURRAY HILL | NJ | 07974-2005 |
| K993787 | OSBORN GROUP, INC. |
14901 WEST 117TH ST. | OLATHE | KS | 66062 |
| K223854 | Owen Mumford Ltd |
Owen Mumford, Brook Hill, Woodstock | Woodstock | OX20 ITU | |
| K162233 | Pathway LLC |
8779 Cottonwood Ave., Suite 105 | Santee | CA | 92071 |
| K962158 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K043143 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K981973 | RAM SCIENTIFIC |
1201 NEW YORK AVENUE N.W. | WASHINGTON | DC | 20005 |
| K983517 | RAM SCIENTIFIC |
1201 NEW YORK AVENUE N.W. | WASHINGTON | DC | 20005 |
| K202325 | Retractable Technologies, Inc. |
511 Lobo Lane | Little Elm | TX | 75068 |
| K122355 | RETRACTABLE TECHNOLOGIES, INC. |
511 Lobo Ln | Little Elm | TX | 75068 |
| K051019 | SARSTEDT, INC. |
1025 ST. JAMES CHURCH RD. | NEWTON | NC | 28658 |
| K220799 | SB-Kawasumi Laboratories, Inc. |
3-15-4 Tonomachi, Kawasaki-ku, Kawasaki-shi | Kanagawa | 210-8602 | |
| K230408 | SB-Kawasumi Laboratories, Inc. |
3-15-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, | Kanagawa | 210-8602 | |
| K223810 | SB-Kawasumi Laboratories, Inc. |
3-25-4 Tonomachi, Kawasaki-Ku | Kawasaki-Shi | 210-8602 | |
| K981035 | SIMS PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K962931 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. | KEENE | NH | 03431 |
| K072783 | SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K081229 | SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K163073 | Sol-Millennium Medical, Inc. |
1735 North Brown Road, Suite 120 | Lawrenceville | GA | 30043 |
| K213718 | Sol-Millennium Medical, Inc. |
315 Shawnee North Drive | Suwanee | GA | 30024 |
| K040107 | STRECK LABORATORIES, INC. |
7002 SOUTH 109TH ST. | LA VISTA | NE | 68128 |
| K936240 | SUDORMED, INC. |
12341 NEWPORT AVE., #D-200 | SANTA ANA | CA | 92705 |
| K060364 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K983490 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K041358 | TERUMO EUROPE N.V. |
125 Blue Ball Road | Elkton | MD | 21921 |
| K971111 | TRI-TECH, INC. |
4019 EXECUTIVE PARK BLVD.,S.E. | SOUTHPORT | NC | 28461 |
| K163508 | Velano Vascular |
1756 Fillmore St. | San Francisco | CA | 94115 |
| K190604 | Velano Vascular |
221 Pine St #200 | San Francisco | CA | 94104 |
| K193569 | Velano Vascular |
221 Pine St #200 | San Francisco | CA | 94104 |
| K152924 | VELANO VASCULAR |
4040 LOCUST ST | PHILADELPHIA | PA | 19104 |
| K142946 | Velano Vascular, Inc. |
1500 Locust St Suite 4311 | Philadelphia | PA | 19102 |
| K201237 | VelanoáVascular |
221áPineáStreetá#200 | SanáFrancisco | CA | 94104 |
| K230080 | Yangzhou Medline Industry Co., Ltd. |
No.108, Jinshan Road, Economic Development Zone | Yangzhou | 225000 | |
| K172763 | Zhejiang Kindly Medical Devices Co.,Ltd |
No.758, 5th Binhai Road, Binhai Industrial Park, | Wenzhou | 325025 |
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