FDA 510(k) Applications for Medical Device:
Injector And Syringe, Angiographic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993774 | ACIST MEDICAL SYSTEMS |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K000013 | ACIST MEDICAL SYSTEMS |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K020892 | ACIST MEDICAL SYSTEMS |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K991103 | ACIST MEDICAL SYSTEMS |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K010390 | ACIST MEDICAL SYSTEMS, INC. |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K040298 | ACIST MEDICAL SYSTEMS, INC. |
7450 FLYING CLOUDS DR. | EDEN PRAIRIE | MN | 55344 |
| K191060 | ACIST Medical Systems, Inc. |
7905 Fuller Road | Eden Prairie | MN | 35344 |
| K203004 | ACIST Medical Systems, Inc. |
7905 Fuller Rd | Eden Prairie | MN | 55344 |
| K171646 | ACIST Medical Systems, Inc. |
7905 Fuller Road | Eden Prairie | MN | 55344 |
| K052744 | ACIST MEDICAL SYSTEMS, INC. |
7450 FLYING CLOUD DR. | EDEN PRAIRIE | MN | 55344 |
| K020333 | ATRION MEDICAL PRODUCTS, INC. |
1426 CURT FRANCIS RD. | ARAB | AL | 35016 |
| K955381 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K960674 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K962141 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K193028 | Bayer Medical Care Inc. |
1 Bayer Drive | Indianola | PA | 15051 |
| K182276 | Bayer Medical Care Inc. |
1 Bayer Drive | Indianola | PA | 15051 |
| K173773 | Bayer Medical Care Inc. |
1 Bayer Drive | Indianola | PA | 15051 |
| K182273 | Bayer Medical Care Inc. |
1 Bayer Drive | Indianola | PA | 15051 |
| K143538 | BAYER MEDICAL CARE INC. |
1 BAYER DRIVE | INDIANOLA | PA | 15051 |
| K192370 | Bayer Medical Care, Inc. |
100 Bayer Blvd | Whippany | NJ | 07981 |
| K973334 | CARDIOVASCULAR INNOVATIONS |
4331 ARCARDY | DALLAS | TX | 75205 |
| K971712 | COEUR LABORATORIES, INC. |
5301 DEPATURE DR. | RALEIGH | NC | 27604 |
| K960965 | COEUR LABORATORIES, INC. |
5301 DEPATURE DR. | RALEIGH | NC | 27604 |
| K032920 | COEUR MEDICAL |
209 CREEKSIDE DR. | WASHINGTON | NC | 27889 |
| K142745 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K150902 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K070798 | COEUR, INC. |
704 CADET COURT | LEBANON | TN | 37087 |
| K133600 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K170431 | Coeur, Inc. |
100 Physicians Way | Lebanon | TN | 37090 |
| K120892 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K090487 | COEUR, INC. |
704 CADET COURT | LEBANON | TN | 37087 |
| K051799 | COEUR, INC. |
704 CADET COURT | LEBANON | TN | 37087 |
| K140469 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K161471 | Coeur, Inc. |
100 Physicians Way | Lebanon | TN | 37090 |
| K955684 | CONTOUR FABRICATORS OF FLORIDA, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K955685 | CONTOUR FABRICATORS OF FLORIDA, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K152978 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LANE | POWELL | TN | 37849 |
| K162088 | ECOMED SOLUTIONS, LLC |
214 TERRACE DR | MUNDELEIN | IL | 60060 |
| K090621 | FLOWCARDIA, INC. |
745 N. PASTORIA AVE. | SUNNYVALE | CA | 94085 |
| K963982 | INVASATEC |
10180 VIKING LN. | EDEN PRAIRIE | MN | 55344 |
| K984231 | INVASATEC |
7450 FLYING CLOUD DR. | EDEN PRAIRIE | MN | 55344 |
| K963071 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K022116 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K031339 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K073592 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K984088 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K042744 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K082212 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K093830 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K001663 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K050456 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K964642 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K993728 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K031483 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K112086 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K113133 | MEDRAD, INC. |
ONE MEDRAD DRIVE | INDIANOLA | PA | 15051 |
| K013815 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K042784 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K033247 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K023183 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K033881 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K072886 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K082905 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K982814 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K991557 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K011991 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K012950 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K984418 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K132928 | MEDRAD, INC. / BAYER MEDICAL CARE, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K160107 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K163084 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K973230 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K083523 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K011811 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K113198 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K062168 | NEMOTO KYORINDO CO., LTD. |
2-27-20 HONGO BUNKYO-KU | TOKYO | 123-0033 | |
| K052633 | NEMOTO KYORINDO CO., LTD. |
2-27-20 HONGO BUNKYO-KU | TOKYO | 123-0033 | |
| K071691 | NEMOTO KYORINDO CO., LTD. |
24992 DEL MONTE ST. | LAGUNA HILLS | CA | 92653-5617 |
| K133189 | NEMOTO KYORINDO CO., LTD. |
2-27-20 HONGO | BUNKYO-KU, TOKYO | 113-0033 | |
| K173450 | Nemoto Kyorindo Co., Ltd. |
2-27-20 Hongo | Bunkyo-ku | 113-0033 | |
| K092896 | NEMOTO KYORINDO CO., LTD. |
2-12-4 AOKI | KAWAGUCHI-SHI, SAITAMA | 332-0031 | |
| K152218 | Osprey Medical |
5600 Rowland Road, Suite 250 | Minnetonka | MN | 55343 |
| K190102 | Osprey Medical Inc. |
5600 Rowland Road Suite 250 | Minnetonka | MN | 55343 |
| K151300 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD | MINNETONKA | MN | 55343 |
| K150485 | Osprey Medical, Inc. |
5600 Rowland Road, Suite 250 | Minnetonka | MN | 55343 |
| K131478 | OSPREY MEDICAL, INC. |
7600 EXECUTIVE DR | EDEN PRAIRIE | MN | 55344 |
| K140425 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD | MINNETONKA | MN | 55343 |
| K142081 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD | MINNETONKA | MN | 55343 |
| K151746 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD | MINNETONKA | MN | 55343 |
| K153141 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD SUITE 250 | MINNETONKA | MN | 55343 |
| K161505 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD SUITE 250 | MINNETONKA | MN | 55343 |
| K163054 | OSPREY MEDICAL, INC. |
5600 ROWLAND ROAD | MINNETONKA | MN | 55343 |
| K171217 | Osprey Medical, Inc. |
5600 Rowland Road | Minnetonka | MN | 55343 |
| K181936 | Osprey Medical, Inc. |
5600 Rowland Rd, Suite 250 | Minnetonka | MN | 55343 |
| K183267 | Osprey Medical, Inc. |
5600 Rowland Rd, Suite 250 | Minnetonka | MN | 55343 |
| K171698 | Osprey Medical, Inc. |
5600 Rowland Road | Minnetonka | MN | 55343 |
| K960430 | SCIENTIFIC DEVICE MANUFACTURER LLC. |
999 ANDERSEN DRIVE, SUITE 120 | SAN RAFAEL | CA | 94901 |
| K082439 | SHANDONG WEIGAO MEDICAL POLYMER CO., LTD |
SUITE 8D, NO.19, LANE 999, | SHANGHAI | 200030 | |
| K170025 | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
NO. 925 JINYUAN YI RD | SHANGHAI | 201803 | |
| K170014 | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
NO. 925 JINYUAN YI RD | SHANGHAI | 201803 | |
| K172694 | Shenyang MasTech Medical Device Co., Ltd. |
Zhaojia Village, Qianjin Street | Shenyang | 110165 | |
| K072696 | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
SUITE 8D, ZHONGXIN ZHONGSHAN | SHANGHAI | 200030 | |
| K151960 | SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD |
INDUSTRIAL ZONE, SHENKENG, LIUYUE COMMUINTY, | SHENZHEN | 518173 | |
| K182289 | Shenzhen Baoan Medical Supplies Co., Ltd |
No.6, Shenkeng Road, Shenkeng Industrial Zone Liuyue | Shenzhen | 518173 | |
| K192657 | Shenzhen Boon Medical Supply Co., Ltd |
No 6 Shenkeng Road, Shenkeng Industrial Zon Liuyue Community | Shenzhen | 518173 | |
| K211564 | Shenzhen Boon Medical Supply Co., Ltd |
No.18 Jirong Road, Shenkeng, Henggang Street, Longgang | Shenzhen | 518173 | |
| K160190 | Sunny Medical Device (Shenzhen) Co.,Ltd. |
56 Lehigh Aisle | Irvine | CA | 92612 |
| K061976 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. | TUSTIN | CA | 92781-2068 |
| K983826 | UNIMACHS CORP. |
7475 WISCONSIN AVENUE, | BETHESDA | MD | 20814 |
| K170279 | Union Medical Shenzhen Co., Ltd. |
Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue | Shenzhen | 518062 | |
| K152906 | WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
NO. 215 XIGANG ROAD, DONGBEITANG | WUXI | 214191 | |
| K201395 | Youwo (Guangzhou) Medical Device Co., Ltd. |
Kaiyuan Avenue, High-Tech Industrial Development Zone | Guangzhou | 510530 |
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