FDA 510(k) Applications for Medical Device:
Dialyzer, High Permeability With Or Without Sealed Dialysate System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K010131 | AKSYS, LTD. |
TWO MARRIOTT DR. | LINCOLNSHIRE | IL | 60069-3700 |
| K992563 | ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 | RONNEBY | S-37221 | |
| K992566 | ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 | RONNEBY | S-37221 | |
| K992564 | ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 | RONNEBY | S-37221 | |
| K992573 | ALTHIN MEDICAL AB |
FRIDHEMSVAGEN 15 | RONNEBY | S-37221 | |
| K954987 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT | PORTLAND | OR | 97222-1298 |
| K970446 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT | PORTLAND | OR | 97222-1298 |
| K964922 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT | PORTLAND | OR | 97222-1298 |
| K955384 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
13520 S.E. PHEASANT COURT | PORTLAND | OR | 97222-1298 |
| K990643 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014-9308 |
| K153344 | Asahi Kasei Medical Co., Ltd. |
1-105 Kanda Jinbocho | Chiyoda-ku | 101-8101 | |
| K082515 | ASAHI KASEI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE, SUITE 300 | ROCKVILLE | MD | 20852 |
| K121409 | ASAHI KASEI MEDICAL CO., LTD. |
154 MAIN STREET, STE 2 | CHARLESTOWN | NH | 03603 |
| K162248 | ASAHI KASEI MEDICAL CO., LTD. |
1-105 KANDA JINBOCHO | Chiyoda-ku | 101-8101 | |
| K051187 | ASAHI KASEI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE, SUITE 300 | ROCKVILLE | MD | 20852 |
| K013418 | ASAHI MEDICAL CO., LTD |
1801 ROCKVILLE PIKE | ROCKVILLE | MD | 20852-1632 |
| K001250 | ASAHI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE PIKE | ROCKVILLE | MD | 20852 |
| K041726 | ASAHI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE PIKE | ROCKVILLE | MD | 20852 |
| K100334 | B. BRAUN AVITUM AG |
901 MARCON BOULEVARD | ALLENTOWN | PA | 18109 |
| K170574 | B. Braun Avitum AG |
Am Buschberg 1 | Melsungen | D-34212 | |
| K083460 | B. BRAUN AVITUM AG |
901 MARCON BOULEVARD | ALLENTOWN | PA | 18109 |
| K143482 | B. Braun Avitum AG |
Am Buschberg 1 | Melsungen | D-34212 | |
| K963440 | B. BRAUN MEDICAL AG |
824 12TH AVE. | BETHLEHEM | PA | 18018 |
| K973322 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K071518 | B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCHWARZENBERGER WAY 73-79 | MELSUNGEN | D-34212 | |
| K163530 | BAXTER HEALTHCARE CORP |
7601 Northland Drive | Brooklyn Park | MN | 55428 |
| K190910 | Baxter Healthcare Corp |
7601 Northland Drive Suite 170 | Brooklyn Park | MN | 55428 |
| K013562 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD. | MC GAW PARK | IL | 60085 |
| K021615 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K030099 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K963203 | BAXTER HEALTHCARE CORP. |
17221 RED HILL AVE. | SANTA ANA | CA | 92711-1150 |
| K970591 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K974652 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD. | MC GAW PARK | IL | 60085 |
| K030974 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K030975 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K992894 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K980656 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K001422 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K023664 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K002210 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K232467 | Baxter Healthcare Corporation |
25212 W. Illinios Route 120 | Round Lake | IL | 60073 |
| K053539 | BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K212216 | Baxter Healthcare Corporation |
One Baxter Parkway | Deerfield | IL | 60015 |
| K171671 | Baxter Healthcare Corporation |
32650 North Wilson Road | Round Lake | IL | 60073 |
| K193482 | Baxter Healthcare Corporation |
7601 Northland Drive | Brooklyn Park | MN | 55428 |
| K213639 | Baxter Healthcare Corporation |
32650 N Wilson Road | Round Lake | IL | 60073 |
| K062079 | BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K083778 | BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K093120 | BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K201809 | Baxter Healthcare Corportation |
25212 W. Illinois Route 120 | Round Lake | IL | 60073 |
| K193542 | Bellco Srl |
Via Camurana 1 | Mirandola | 41037 | |
| K231406 | Bellco Srl |
Via Camurana 1 | Mirandola | 41037 | |
| K160558 | BELLCO Srl |
via Camurana 1 | Mirandola | 41037 | |
| K093379 | BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 | FOXBORO | MA | 02035 |
| K971180 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K060008 | CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 | BROOKLYN PARK | MN | 55428 |
| K071854 | CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 | BROOKLYN PARK | MN | 55428 |
| K192756 | CHF Solutions, Inc. |
12988 Valley View Road | Eden Prairie | MN | 55344 |
| K050609 | CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 | BROOKLYN PARK | MN | 55428 |
| K040489 | CHF SOLUTIONS, INC. |
SUITE 170-7601 NORTHLAND DR. | BROOKLYN PARK | MN | 55428 |
| K023224 | CHF SOLUTIONS, INC. |
SUITE 170-7601 NORTHLAND DR. | BROOKLYN PARK | MN | 55428 |
| K062922 | CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 | BROOKLYN PARK | MN | 55428 |
| K070512 | CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 | BROOKLYN PARK | MN | 55428 |
| K023874 | CHF SOLUTIONS, INC. |
SUITE 170-7601 NORTHLAND DR. | BROOKLYN PARK | MN | 55428 |
| K024124 | CHF SOLUTIONS, INC. |
SUITE 170-7601 NORTHLAND DR. | BROOKLYN PARK | MN | 55428 |
| K013733 | CHF SOLUTIONS, INC. |
1730 PENNSYLVANIA AVE., N.W. | WASHINGTON | DC | 20006 |
| K955592 | COBE RENAL CARE, INC. |
1185 OAK ST. | LAKEWOOD | CO | 80215-4407 |
| K960474 | COBE RENAL CARE, INC. |
1185 OAK ST. | LAKEWOOD | CO | 80215-4407 |
| K951311 | COBE RENAL CARE, INC. |
1185 OAK ST. | LAKEWOOD | CO | 80215-4407 |
| K955487 | COBE RENAL CARE, INC. |
1185 OAK ST. | LAKEWOOD | CO | 80215-4407 |
| K946279 | COBE RENAL CARE, INC. |
1185 OAK ST. | LAKEWOOD | CO | 80215-4407 |
| K023509 | DAVITA CLINICAL RESEARCH (TRRI) |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K233557 | Deka Research and Development |
340 Commercial Street | Manchester | NH | 03101 |
| K193005 | Dialco Medical Inc. |
135 The West Mall, Unit 2 | Toronto | M9C1C2 | |
| K233798 | Diality, Inc. |
181 Technology Drive | Irvine | CA | 92618 |
| K021732 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K982134 | DYNAMIC TECHNOLOGY CORP. |
SCIENCE-BASED INDUSTRIAL PARK | HSINCHU | 300 | |
| K011537 | DYNAMIC TECHNOLOGY CORP. |
SCIENCE-BASED INDUSTRIAL PARK | HSINCHU | 300 | |
| K070320 | EDWARDS LIFESCIENCES SERVICES GMBH |
BUSINESS & TECHNOLOGY CENTER | STEVENAGE, HERTSFORDSHIRE | SG1 2DX | |
| K090682 | EDWARDS LIFESCIENCES SERVICES GMBH |
BIOPARK | WELWYN GARDEN CITY | AL7 3AX | |
| K231534 | Fresenius Medical Care |
920 Winter Street | Waltham | MA | 02451 |
| K994267 | FRESENIUS MEDICAL CARE |
TWO LEDGEMONT CENTER | LEXINGTON | MA | 02420 |
| K111639 | FRESENIUS MEDICAL CARE |
920 Winter Street | Waltham | MA | 02451 |
| K113427 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K982926 | FRESENIUS MEDICAL CARE NORTH AMERICA |
10 OAK POINT | WRENTHAM | MA | 02093 |
| K080964 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K991520 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K003498 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K002277 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K043244 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K070222 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K034064 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K031378 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K093902 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K162488 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. | WALTHAM | MA | 02451 |
| K152367 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER STREET | WALTHAM | MA | 02451-1457 |
| K082414 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K123262 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K120505 | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 Winter Street | Waltham | MA | 02451-1457 |
| K101715 | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 Winter Street | Waltham | MA | 02451-1457 |
| K192928 | Fresenius Medical Care Reanal Therapies Group LLC |
920 Winter Street | Waltham | MA | 02451 |
| K150708 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K153449 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 WINTER STREET | WALTHAM | MA | 02451 |
| K222952 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K173972 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K231125 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K243237 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MD | 02451 |
| K131908 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K243505 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K242053 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K243874 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K220721 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K220281 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K240394 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K192707 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K203062 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K120017 | FRESENIUS MEDICAL CARE, NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451 |
| K121341 | FRESENIUS MEDICAL CARE, NORTH AMERICA |
920 WINTER STREET | WALTHAM | MA | 01854 |
| K133299 | FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER |
920 WINTER ST. | WALTHAM | MA | 02451 |
| K961465 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K974584 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K992275 | FRESENIUS USA, INC. |
110 MASON CR | CONCORD | CA | |
| K072093 | GAMBRO |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K982413 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K982760 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K970253 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K962427 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K982414 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K980386 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K981681 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K030592 | GAMBRO RENAL CARE PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K993064 | GAMBRO RENAL CARE PRODUCTS |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K010985 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K010667 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K060195 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K051520 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K041005 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K042938 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K001156 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K011221 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K010805 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K062090 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K072232 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K103832 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K040255 | GAMBRO RENAL PRODUCTS, INC. |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K063183 | GAMBRO RENAL PRODUCTS, INC. |
7307 GLOUCHESTER DRIVE | EDINA | MN | 55435 |
| K110823 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K080519 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K131516 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K130039 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K083158 | GAMBRO, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K070643 | GAMBRO, INC. |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K032431 | GAMBRO, INC. |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K140866 | HOME DIALYSIS PLUS |
257 HUMBOLDT COURT | SUNNYVALE | CA | 94089 |
| K003023 | HOSPAL INDUSTRIE |
14401 W. 65th Way | Arvada | CO | 80004-3599 |
| K123288 | MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 | RASTATT | 76437 | |
| K000724 | MEDICA S.R.L. |
100 MAIN ST. | CONCORD | MA | 01742 |
| K983085 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K980859 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K071298 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K050952 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K962707 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K000028 | MINNTECH CORP. |
14905 28TH AVE. N. | MINNEAPOLIS | MN | 55447 |
| K210575 | Nephros |
380 Lackawanna Place | South Orange | NJ | 07079 |
| K112314 | NEPHROS, INC. |
41 GRAND AVE. | RIVER EDGE | NJ | 07661 |
| K050603 | NEPHROS, INC. |
3960 BROADWAY | NEW YORK | NY | 10032 |
| K091978 | NIKKISO CO. LTD. |
4-2-17 HONGO | TOKYO | 113-0033 | |
| K061519 | NIKKISO CO. LTD. |
4-2-1 YUSHIMA | TOKYO | 113-0034 | |
| K953996 | NIKKISO CO. LTD. |
4503 MOORLAND AVE. | MINNEAPOLIS | MN | 55435 |
| K242155 | NIKKISO CO., LTD. |
20-3, Ebisu 4-Chome, Shibuya-ku | Tokyo | 150-6022 | |
| K152938 | NIKKISO, CO.,LTD. |
20-3, EBISU 4-CHOME | SHIBUYA-KU | 150-6022 | |
| K122347 | NIPRO MEDICAL CORPORATION |
6695 RIVER CREST PT | SUWANEE | GA | 30024 |
| K140191 | NIPRO MEDICAL CORPORATION |
3150 NW 107 AVE., | MIAMI | FL | 33172 |
| K131381 | NIPRO MEDICAL CORPORATION |
6695 RIVER CREST PT | SUWANEE | GA | 30024 |
| K131935 | NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. | MIAMI | FL | 33172 |
| K160444 | NIPRO MEDICAL CORPORATION |
3150 NW 107TH AVE. | DORAL | FL | 33172 |
| K122343 | NIPRO MEDICAL CORPORATION |
6695 RIVER CREST PT | SUWANEE | GA | 30024 |
| K182940 | Nipro Medical Corporation |
3150 NW 107th Ave. | Doral | FL | 33172 |
| K232803 | NxStage Medical Inc. |
350 Merrimack Street | Lawrence | MA | 01843 |
| K170469 | NxStage Medical, Inc |
350 Merrimack Street | Lawrence | MA | 01843 |
| K001283 | NXSTAGE MEDICAL, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K011269 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | S. LAWRENCE | MA | 01843 |
| K050727 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K040696 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K012510 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | S. LAWRENCE | MA | 01843 |
| K131050 | NXSTAGE MEDICAL, INC. |
350 Merrimack St | LAWRENCE | MA | 01843 |
| K014152 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K061837 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K183158 | NxStage Medical, Inc. |
350 Merrimack Street | Lawrence | MA | 01843 |
| K122051 | NXSTAGE MEDICAL, INC. |
350 Merrimack St | LAWRENCE | MA | 01843 |
| K140526 | NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET | LAWRENCE | MA | 01843 |
| K171331 | NxStage Medical, Inc. |
350 Merrimack Street | Lawrence | MA | 01843 |
| K041424 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K050525 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K123395 | NXSTAGE MEDICAL, INC. |
350 Merrimack St | LAWRENCE | MA | 01843 |
| K032356 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K133547 | NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET | LAWRENCE | MA | 01843 |
| K093069 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K143313 | NxStage Medical, Inc. |
350 Merrimack Street | Lawrence | MA | 01843 |
| K020858 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K071263 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K113023 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K132602 | NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET | LAWRENCE | MA | 01843 |
| K230632 | NxStage Medical, Inc. |
350 Merrimack St. | Lawrence | MA | 01843 |
| K150880 | Outset Medical |
1830 Bering Drive | San Jose | CA | 95112 |
| K160881 | OUTSET MEDICAL, INC. |
1830 BERING DRIVE | SAN JOSE | CA | 95112 |
| K200741 | Outset Medical, Inc. |
1830 Bering Drive | San Jose | CA | 95112 |
| K211370 | Outset Medical, Inc. |
3052 Orchard Drive | San Jose | CA | 95134 |
| K190793 | Outset Medical, Inc. |
1830 Bering Drive | San Jose | CA | 95112 |
| K223248 | Outset Medical, Inc. |
3052 Orchard Drive | San Jose | CA | 95134 |
| K233335 | Outset Medical, Inc. |
3052 Orchard Drive | San Jose | CA | 95134 |
| K232776 | Outset Medical, Inc. |
3052 Orchard Drive | San Jose | CA | 95134 |
| K222067 | Quanta Dialysis Technologies Ltd |
Tything Road | Alcester | B49 6EU | |
| K210661 | Quanta Dialysis Technologies Ltd |
Tything Road | Alcester | B49 6EU | |
| K193670 | Quanta Dialysis Technologies Ltd. |
Tything Road | Alcester | B49 6EU | |
| K093964 | RENAL SOLUTIONS INC. |
770 COMMONWEALTH DRIVE | WARRENDALE | PA | 15086 |
| K121497 | RENAL SOLUTIONS INC. |
770 COMMONWEALTH DRIVE | WARRENDALE | PA | 15086 |
| K103564 | RENAL SOLUTIONS, INC. |
770 COMMONWEALTH DR SUITE 101 | WARRENDALE | PA | 15086 |
| K970739 | RESEARCH MEDICAL, INC. |
6864 SOUTH 300 WEST | MIDVALE | UT | 84047 |
| K243264 | Sorin Group Italia S.r.l. |
Via Statale 12 Nord, 86 | Mirandola ( Modena) | 41037 | |
| K081313 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K170790 | Spectral Medical Inc. |
135 The West Mall, Unit 2 | Toronto | M9C 1C2 | |
| K232171 | Tecnoideal America |
7600 Standish Place | Derwood | MD | 20855 |
| K973516 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K013550 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K003425 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K994198 | TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. | BELLAIRE | TX | 77401-5010 |
| K002512 | TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. | BELLAIRE | TX | 77401-5010 |
| K030050 | TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. | BELLAIRE | TX | 77401-5010 |
| K080650 | TRANSVIVO INC. |
3067 RESEARCH DRIVE | RICHMOND | CA | 94806 |
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