FDA 510(k) Applications for Medical Device:
Pump, Infusion, Insulin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K071788 | ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. | ALAMEDA | CA | 94502 |
| K083225 | ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. | ALAMEDA | CA | 94502 |
| K051041 | ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. | ALAMEDA | CA | 94502 |
| K042873 | ANIMAS CORP. |
200 LAWRENCE DR. | WEST CHESTER | PA | 19380 |
| K063674 | ANIMAS CORP. |
200 LAWRENCE DR. | WEST CHESTER | PA | 19380 |
| K022394 | ANIMAS CORP. |
590 E. LANCASTER AVE. | FRAZER | PA | 19355 |
| K032257 | ANIMAS CORP. |
590 E. LANCASTER AVE. | FRAZER | PA | 19355 |
| K021439 | ANIMAS CORP. |
590 E. LANCASTER AVE. | FRAZER | PA | 19355 |
| K993184 | ANIMAS CORP. |
590 E. LANCASTER AVE. | FRAZER | PA | 19355 |
| K080639 | ANIMAS CORP. |
200 LAWRENCE DR. | WEST CHESTER | PA | 19380 |
| K142619 | ASANTE SOLUTIONS, INC |
352 EAST JAVA DRIVE | SUNNYVALE | CA | 94089 |
| K122483 | Asante Solutions, Inc. |
352 E Java Dr | Sunnyvale | CA | 94089 |
| K050971 | BIOVALVE TECHNOLOGIES, INC. |
155 FLANDERS RD. | WESTBOROUGH | MA | 01581 |
| K013807 | CANE SRL |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K020655 | DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K991376 | DISETRONIC MEDICAL SYSTEMS |
7690 CAMERON CIRCLE | FT. MEYERS | FL | 33912 |
| K994186 | DISETRONIC MEDICAL SYSTEMS |
7690 CAMERON CIRCLE | FT. MEYERS | FL | 33912 |
| K973044 | DISETRONIC MEDICAL SYSTEMS |
5201 EAST RIVER RD. | MINNEAPOLIS | MN | 55421-1014 |
| K060876 | DISETRONIC MEDICAL SYSTEMS AG |
9115 Hague Road | Indianapolis | IN | 46250-0457 |
| K042887 | DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERGSTRASSE 190 | BURGDORF | 3401 | |
| K021725 | DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERSTRASSE 190, POSTFACH | BURGDORF | CH-3401 | |
| K023471 | DISETRONIC MEDICAL SYSTEMS AG |
5151 PROGRAM AVE. | ST. PAUL | MN | 55112-1014 |
| K043000 | DISETRONIC MEDICAL SYSTEMS AG |
9115 Hague Road | Indianapolis | IN | 46250 |
| K022831 | DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERSTRASSE 190, POSTFACH | BURGDORF | CH-3401 | |
| K031373 | INSULET CORP. |
100 CUMMINGS CENTER STE 239G | BEVERLY | MA | 01915 |
| K111669 | INSULET CORPORATION |
9 OAK PARK DR. | BEDFORD | MA | 01730 |
| K042792 | INSULET CORPORATION |
9 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K180045 | Insulet Corporation |
600 Technology Park Drive | Billerica | MA | 01821 |
| K223372 | Insulet Corporation |
100 Nagog Park | Acton | MA | 01720 |
| K160252 | INSULET CORPORATION |
600 TECHNOLOGY PARK DRIVE | BILLERICA | MA | 01821 |
| K162296 | INSULET CORPORATION |
600 TECHNOLOGY PARK DRIVE | BILLERICA | MA | 01821 |
| K131294 | INSULET CORPORATION |
9 OAK PARK DR. | BEDFORD | MA | 01730 |
| K140439 | INSULET CORPORATION |
9 OAK PARK DR. | BEDFORD | MA | 01730 |
| K192659 | Insulet Corporation |
100 Nagog Park | Acton | MA | 01720 |
| K182630 | Insulet Corporation |
600 Technology Park Drive, Suite 200 | Billerica | MA | 01821 |
| K122953 | INSULET CORPORATION |
9 OAK PARK DR. | BEDFORD | MA | 01730 |
| K211575 | Insulet Corporation |
100 Nagog Park | Acton | MA | 01720 |
| K082590 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K100567 | M2 GROUP HOLDINGS, INC. |
1012 STEWART DRIVE | SUNNYVALE | CA | 94085 |
| K090245 | MEDINGO LTD. |
YOQNEAM INDUSTRIAL PARK BLDG.7 | YOQNEAM | 20692 | |
| K093364 | MEDINGO LTD. |
YOQNEAM INDUSTRIAL PARK BLDG.7 | YOQNEAM | 20692 | |
| K032164 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K241622 | Medtronic MiniMed |
18000 Devonshire St | Northridge | CA | 91325 |
| K053177 | MEDTRONIC MINIMED |
18000 DEVONSHIRE STREET | NORTHRIDGE | CA | 91325 |
| K040676 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K120206 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K041318 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K990801 | MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. | SYLMAR | CA | 91342 |
| K993012 | MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. | SYLMAR | CA | 91342 |
| K972107 | MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. | SYLMAR | CA | 91342 |
| K960001 | MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. | SYLMAR | CA | 91342 |
| K963948 | MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. | SYLMAR | CA | 91342 |
| K041317 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K073356 | MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325-1219 |
| K210714 | Medtronic MiniMed, Inc. |
18000 Devonshire Street | Northridge | CA | 91325 |
| K030531 | MINIMED, INC. |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325 |
| K031541 | MINIMED, INC. |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325 |
| K240158 | Modular Medical, Inc. |
10740 Thornmint Road | San Diego | CA | 92127 |
| K070844 | NILIMEDIX LTD. |
31 HAAVODA ST. | BINYAMINA | ||
| K071613 | NIPRO DIABETES SYSTEMS, INC. |
3361 ENTERPRISE PKWY. | MIRAMAR | FL | 33025 |
| K050312 | NIPRO DIABETES SYSTEMS, INC. |
3361 ENTERPRISE WAY | MIRAMAR | FL | 33025 |
| K013309 | NIPRO DIABETES SYSTEMS, INC. |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514 |
| K111353 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K082595 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K050760 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K062323 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K031738 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD | ST. PAUL | MN | 55112 |
| K001604 | SOOIL DEVELOPMENT CO., LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K022317 | SOOIL DEVELOPMENT CO., LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K063126 | SOOIL DEVELOPMENT CO., LTD. |
5677 OBERLIN DRIVE, SUITE 101 | SAN DIEGO | CA | 92121 |
| K143189 | Tandem Diabetes Care, Inc. |
11045 Roselle Street | San Diego | CA | 92121 |
| K111210 | TANDEM DIABETES CARE, INC. |
11045 ROSELLE STREET | SAN DIEGO | CA | 92121 |
| K160056 | Tandem Diabetes Care, Inc. |
11045 Roselle Street | San Diego | CA | 92121 |
| K133593 | TANDEM DIABETES CARE, INC. |
1835 MARKET STREET | PHILADELPHIA | PA | 19103 |
| K141758 | TANDEM DIABETES CARE, INC. |
1835 MARKET STREET, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K160482 | Tandem Diabetes Care, Inc. |
11045 Roselle Street | San Diego | CA | 92121 |
| K162080 | Tandem Diabetes Care, Inc. |
11045 Roselle Street | San Diego | CA | 92121 |
| K103825 | VALERITAS, INC. |
800 BOSTON TURNPIKE | SHREWSBURY | MA | 01545 |
| K100504 | VALERITAS, LLC |
800 BOSTON TURNPIKE | SHREWSBURY | MA | 01545 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
