FDA 510(k) Applications for Medical Device:
Accessories, Pump, Infusion
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K083221 | AIDERA AB |
MEDICINAREGATAN 8A | GOTEBORG | SE 413 46 | |
| K101806 | AIDERA AB |
MEDICINAREGATAN 8A | GOTEBORG | SE 413 46 | |
| K971213 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K971212 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K972780 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K971237 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K971234 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K972089 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K972779 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K970786 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K142333 | AMERICAN I.V. PRODUCTS, INC dba AIV, INC |
7485 SHIPLEY AVE | HARMANS | MD | 21077 |
| K120209 | AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. | HARMANS | MD | 21077 |
| K080587 | ANIMAS CORP. |
200 LAWRENCE DR. | WEST CHESTER | PA | 19380 |
| K023890 | APPRO HEALTHCARE, INC. |
847 MAIN ST. | BUFFALO | NY | 14203 |
| K173531 | B. Braun Medical Inc. |
901 Marcon Blvd | Allentown | PA | 18109 |
| K191910 | B. Braun Melsugen AG |
Carl-Braun-Strasse 1 | Melsungen | 34212 | |
| K201634 | Chengdu Shifeng Medical Technology Co., Ltd. |
No. 31, Yinyuan Road | Jinhua Town, Xinjin County | 611438 | |
| K980165 | DATREND SYSTEMS, INC. |
UNIT 106-3070 NORLAND AVE. | BURNABY, BRITISH COLUMBIA | V5B 3A6 | |
| K220695 | Elite Biomedical Solutions |
756 Cincinnati-Batavia Pike Suite C | Cincinnati | OH | 45245 |
| K962159 | FAULDING MEDICAL DEVICE CO. |
8777 EAST VIA DE VENTURA, | SCOTTSDALE | AZ | 85258 |
| K990091 | FAULDING PHARMACEUTICAL CO. |
11 COMMERCE DR. | CRANFORD | NJ | 07016 |
| K230718 | Gilero, LLC |
635 Davis Drive Ste 100 | Morrisville | NC | 27560 |
| K970678 | HARVARD APPARATUS, INC. |
22 PLEASANT ST. | S. NATICK | MA | 01760 |
| K051079 | HOSPICARE, INC. |
275 NORTH FIELD DRIVE | LAKE FOREST | IL | 60045 |
| K160492 | Hospira, Inc |
375 North Field Drive | Lake Forest | IL | 60045 |
| K171346 | ICU Medical |
600 N. Field Drive | Lake Forest | IL | 60045 |
| K961486 | IVAC MEDICAL SYSTEMS |
10221 WATERIDGE CIRCLE | SAN DIEGO | CA | 92121 |
| K142374 | ivWatch, LLC |
469 McLaws Circle | Williamsburg | VA | 23185 |
| K132618 | LIFESCAN, INC. |
965 CHESTERBROOK BOULEVARD | WAYNE | PA | 19087 |
| K070438 | MEDTRONIC MINIMED, INC. |
18000 DEVONSHIRE STREET | NORTHRIDGE | CA | 91325 |
| K021974 | MINIMED, INC. |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325 |
| K012262 | NATIONAL CUSTOM ENT., INC. |
1133 EAST CLIFF RD. | BURNSVILLE | MN | 55337 |
| K012259 | NATIONAL CUSTOM ENT., INC. |
1133 EAST CLIFF RD. | BURNSVILLE | MN | 55337 |
| K012266 | NATIONAL CUSTOM ENT., INC. |
1133 EAST CLIFF RD. | BURNSVILLE | MN | 55337 |
| K030936 | RITA MEDICAL SYSTEMS INC |
967 N. SHORELINE BLVD. | MOUNTAIN VIEW | CA | 94043 |
| K080227 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K082783 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K072955 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K091181 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K071418 | SOOIL DEVELOPMENT CO., LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K193654 | WellDoc, Inc |
10221 Wincopin Circle, Suite 150 | Columbia | MD | 21044 |
| K100066 | WELLDOC, INC |
1501 SAINT PAUL STREET | BALTIMORE | MD | 21202 |
| K162225 | WellDoc, Inc |
10221 Wincopin Circle Suite 150 | Columbia | MD | 21044 |
| K162532 | WELLDOC, INC |
10221 WINCOPIN CIRCLE SUITE 150 | COLUMBIA | MD | 21044 |
| K112370 | WELLDOC, INC |
1501 SAINT PAUL STREET | BALTIMORE | MD | 21202 |
| K120314 | WELLDOC, INC |
1501 SAINT PAUL STREET | BALTIMORE | MD | 21202 |
| K141273 | WELLDOC, INC |
1501 SAINT PAUL STREET | BALTIMORE | MD | 21202 |
| K190013 | WellDoc, Inc. |
10221 Wincopin Circle, Suite 150 | Columbia | MD | 21044 |
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