FDA 510(k) Applications for Medical Device:
Subsystem, Water Purification
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K080703 | 4M VENTURES, INC. |
1415 HALSEY WAY | CARROLLTON | TX | 75007-4455 |
| K001282 | AMERICAN INDUSTRIAL WATER |
327 S. HYDRAULIC | WICHITA | KS | 67211 |
| K121022 | AMERIWATER |
1303 STANLEY AVE. | DAYTON | OH | 45404 |
| K133783 | AMERIWATER |
1303 STANLEY AVE. | DAYTON | OH | 45404 |
| K142285 | AmeriWater |
1303 Stanley Avenue | Dayton | OH | 45404 |
| K111740 | AMERIWATER |
1303 STANLEY AVE. | DAYTON | OH | 45404 |
| K991519 | AMERIWATER |
1257 STANLEY AVE. | DAYTON | OH | 45404 |
| K131904 | AMERIWATER |
1303 STANLEY AVE. | DAYTON | OH | 45404 |
| K021560 | AMERIWATER |
1257 STANLEY AVE. | DAYTON | OH | 45404 |
| K131622 | AMERIWATER |
1303 STANLEY AVE. | DAYTON | OH | 45404 |
| K030059 | AMERIWATER |
1257 STANLEY AVE. | DAYTON | OH | 45404 |
| K223656 | AmeriWater, Llc |
3345 Stop 8 Rd | Dayton | OH | 45414 |
| K102892 | AQUA SCIENCES, INC. |
565 FILLMORE AVENUE | TONAWANDA | NY | 14150 |
| K010592 | AQUA WATER TREATMENT, INC. |
8195 EAST BAY BLVD. | NAVARRE | FL | 32566 |
| K112331 | ARION WATER, INC. |
1 COMMERCE WAY | CARVER | MA | 02330 |
| K974127 | AUTOMATA INSTRUMENTATION, INC. |
15600 NORTH 78TH ST. | SCOTTSDALE | AZ | 85260-1735 |
| K223479 | B. Braun Medical Inc. |
901 Marcon Blvd | Allentown | PA | 18109 |
| K211035 | Baxter Healthcare Corporation |
25212 W. Illinois Route 120 | Round Lake | IL | 60073 |
| K051620 | BETTER WATER, INC. |
698 SWAN DR. | SMYRNA | TN | 37167 |
| K954928 | BETTER WATER, INC. |
698 SWAN DR. | SMYRNA | TN | 37167 |
| K161844 | BETTER WATER, LLC. |
698 SWAN DR. | SMYRNA | TN | 37167 |
| K030348 | BIOLAB EQUIPMENT CANADA LTD. |
128 GRANDVIEW AVE. | THORNHILL, ONTARIO | L3T 1H6 | |
| K014169 | BOB J. JOHNSON & ASSOC., INC |
7715 MAINLAND DR. # 115 | SAN ANTONIO, | TX | 78250 |
| K060942 | BOB J. JOHNSON & ASSOCIATES |
16420 W. HARDY RD., STE. 100 | HOUSTON | TX | 77060 |
| K171099 | Cantel |
14550 28th Avenue North | Minneapolis | MN | 55447 |
| K993806 | CLARIGEN, INC. |
5922 FARNSWORTH COURT | CARLSBAD | CA | 92008 |
| K082400 | CULLIGAN SOFT WATER SERVICE CO. |
6030 CULLIGAN WAY | MINNETONKA | MN | 55345 |
| K021352 | DAYTON WATER SYSTEMS |
430 LEO ST. | DAYTON | OH | 45404 |
| K981680 | DAYTON WATER SYSTEMS |
1288 MCCOOK AVE. | DAYTON | OH | 45404 |
| K043344 | DIALYSIS SERVICES, INC. |
3620 KELTON JACKSON RD. | SPRINGFIELD | TN | 37172 |
| K083712 | DIPURE, LLC. |
1919 EDWARDS STREET | HOUSTON | TX | 77007 |
| K231410 | Evoqua Water Technologies LLC |
558 Clark Road | Tewksbury | MA | 01876 |
| K071104 | FLIER'S QUALITY WATER SYSTEMS INC |
7425 CLYDE PARK AVENUE SW | BYRON CENTER | MI | 49315 |
| K991495 | FLUID PROCESS SYSTEMS, INC. |
998-A PEYTON RD. | EL PASO | TX | 79927 |
| K182367 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K213507 | Fresenius Medical Care Rental Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K944493 | G.E.M. WATER SYSTEMS |
5940 LAKESHORE DR. | CYPRESS | CA | 90630 |
| K974899 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K981085 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K003957 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K042797 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K093608 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K061782 | GAMBRO SERVICES, INC. |
7307 GLOUCHESTER DRIVE | EDINA | MN | 55435 |
| K022747 | HYDROPURE SYSTEMS, INC. |
3319 BARTLETT BLVD. | ORLANDO | FL | 32817 |
| K041163 | ISOPURE CORP. |
129 CITIZENS BLVD. | SIMPSONVILLE | KY | 40067 |
| K993200 | ISOPURE CORP. |
11700 COMMONWEALTH DR. | LOUISVILLE | KY | 40299 |
| K032004 | LAUER LTD., HONG KONG |
SPEICHERMATT 9 | WITTLINGEN | 79599 | |
| K124059 | LAUER MEMBRAN WASSERTECHNIK GMBH |
9 SPEICHERMATT | WITTLINGEN | DE 79599 | |
| K133149 | MAR COR PURIFICATION, INC. |
14605 28TH AVENUE NORTH | MINNEAPOLIS | MN | 55447 |
| K200670 | Mar Cor Purification, Inc. |
14550 28th Avenue North | Minneapolis | MN | 55447 |
| K192398 | Mar Cor Purification, Inc. |
14550 28th Avenue North | Minneapolis | MN | 55447 |
| K110578 | MAR COR PURIFICATION, INC. |
14605 28TH AVENUE NORTH | MINNEAPOLIS | MN | 55447 |
| K945559 | MAR COR SERVICES, INC. |
364 MAPLE AVE. | HARLEYSVILLE | PA | 19438 |
| K003877 | MAR COR SERVICES, INC. |
364 MAPLE AVE. | HARLEYSVILLE | PA | 19438 |
| K153329 | MED-TECH WATER SYSTEMS INC |
1755 WOOLNER AVENUE SUITE B | FAIRFIELD | CA | 94533 |
| K031832 | MEGA SERVICES |
106 LOST MEADOWS DRIVE | CIBOLO | TX | 78108 |
| K983126 | MINNTECH CORP. |
14905 28TH AVE. N. | MINNEAPOLIS | MN | 55447 |
| K001755 | MPW INDUSTRIAL WATER SERVICES, INC. |
2848 INTERSTATE PKWY. | BRUNSWICK | OH | 44212 |
| K041884 | MUELLER WATER CONDITIONING, INC. |
1500 SHERWOOD FOREST DR. | HOUSTON | TX | 77043-3899 |
| K993877 | NELSON ENVIRONMENTAL TECHNOLOGIES, INC. |
301-E N. MCCOLL RD. | MCALLEN | TX | 78501 |
| K161304 | Nephros Inc. |
41 Grand Ave | River Edge | NJ | 07661 |
| K110285 | NEPHROS, INC. |
41 GRAND AVE. | RIVER EDGE | NJ | 07661 |
| K090885 | NEPHROS, INC. |
41 GRAND AVE. | RIVER EDGE | NJ | 07661 |
| K001811 | NEU-ION, INC. |
7200 RUTHERFORD RD. | BALTIMORE | MD | 21244-2704 |
| K092481 | NEW AQUA LLC (DBA AQUA SYSTEMS) |
114 VISTA PARKWAY | AVON | IN | 46123 |
| K042089 | NX STAGE MEDICAL INC |
439 SOUTH UNION ST. STE 501 | LAWRENCE | MA | 01843 |
| K033648 | PERFORMANCE WATER SYSTEMS, LLC |
13601 SOUTH KENTON AVE. | CRESTWOOD | IL | 60445 |
| K011005 | PURE WATER SOLUTIONS, INC. |
3925 WEST NORTHSIDE DR. | JACKSON | MS | 39209 |
| K994279 | PURE WATER SOLUTIONS, INC. |
14550 EAST EASTER AVE., #800 | ENGLEWOOD | CO | 80112-4271 |
| K992786 | PURE WATER, INC. |
305 WEST MARKET ST. | ANDERSON | SC | 29624 |
| K022448 | PURITY WATER COMPANY OF SAN ANTONIO, INC. |
803 EVIAN | SAN ANTONIO | TX | 78258 |
| K983239 | RASCO |
1635-2 WOODSIDE DR. | WOODBRIDGE | VA | 22191 |
| K000249 | SCHAEFER WATER CENTERS |
HIGHWAY 61-67 | HERCULANEUM | MO | 63048 |
| K993520 | SERV-A-PURE CO. |
1101 COLUMBUS AVE. | BAY CITY | MI | 48708 |
| K042018 | SIMPLY CLEAN AIR & WATER, INC. |
28 SHEPARD DRIVE | NEWINGTON | CT | 06131 |
| K151637 | Specialty Water Technologies |
1020 Industrial Drive | Orlinda | TN | 37141 |
| K072158 | STAUBACH BARROR WATER SYSTEMS, INC. |
495 ROTTERDAM IND. PARK | SCHENECTADY | NY | 12306 |
| K002045 | TOTAL WATER TREATMENT SYSTEMS, INC. |
4806 EAST BROADWAY | MADISON | WI | 53716 |
| K030652 | U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K013677 | U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K980182 | U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K123282 | ULTRAPURE & INDUSTRIAL SERVICES LLC |
4429 MINT WAY | DALLAS | TX | 75236 |
| K991916 | VIRGINIA WATER SYSTEMS, INC. |
7433 WHITEPINE RD. | RICHMOND | VA | 23237 |
| K133829 | VIVONIC GMBH |
KURFUERST-EPPSTEIN-RING 4 | SAILAUF | 63877 | |
| K143617 | VIVONIC GMBH |
KURFUERST-EPPSTEIN-RING 4 | SAILAUF | 63877 | |
| K994292 | WATER & POWER TECHNOLOGIES, INC. |
3535 FIREWHEEL DR. | FLOWER MOUND | TX | 75028-2628 |
| K983512 | WATER VAULT, INC. |
2003 BLAIR BLVD. | NASHVILLE | TN | 37212 |
| K964539 | ZYZATECH WATER SYSTEMS, INC. |
7848 S. 202ND ST. | KENT | WA | 98032 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
