FDA 510(k) Applications for Medical Device:
Apparatus, Autotransfusion
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K043140 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K201305 | Atrium Medical Corporation |
40 Continental Blvd. | Merrimack | NH | 03054 |
| K955010 | BOEHRINGER LABORATORIES |
500 E. WASHINGTON ST. | NORRISTOWN | PA | 19401 |
| K014187 | BOEHRINGER LABORATORIES |
500 E. WASHINGTON ST. | NORRISTOWN | PA | 19401 |
| K962689 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K991986 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K974897 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K973627 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K060482 | CYTORI THERAPEUTICS, INC. |
3020 CALLAN ROAD | SAN DIEGO | CA | 92121-1109 |
| K970857 | DAVIS & GECK, INC. |
1915 OLIVE ST. | ST. LOUIS | MO | 63103 |
| K964070 | DEKNATEL, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K963850 | DEKNATEL, INC. |
600 AIRPORT ROAD, P.O. BOX | FALL RIVER | MA | 02722-2980 |
| K963098 | DEKNATEL, INC. |
600 AIRPORT RD. | FALL RIVER | MA | 02720 |
| K982650 | DIDECO S.P.A. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K020647 | DIDECO S.P.A. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K951592 | DUXBURY SCIENTIFIC INC. |
183 WHITING ST. | HINGHAM | MA | 02043 |
| K982241 | DUXBURY SCIENTIFIC INC. |
80 SEABURY POINT RD. | DUXBURY | MA | 02332 |
| K971274 | FRESENIUS AG |
53 KENNEDY RD. | FOSTER | RI | 02825 |
| K960006 | FRESENIUS AG |
53 KENNEDY RD. | FOSTER | RI | 02825 |
| K984233 | FRESENIUS HEMOTECHNOLOGY, INC. |
110 MASON CIRCLE SUITE A | CONCORD | CA | 94520-1238 |
| K012178 | FRESENIUS HEMOTECHNOLOGY, INC. |
6675 185TH AVE. NE, SUITE 100 | REDMOND | WA | 98052 |
| K160735 | FRESENIUS KABI AG |
ELSE-KRONER-STRASSE 1 | Bad Homburg | 61352 | |
| K180831 | Fresenius Kabi AG |
Else-Kroner-Strasse 1 | Bad Homburg | 61352 | |
| K192368 | Fresenius Kabi AG |
Else-Kroner-Strasse 1 | Bad Homburg | 61352 | |
| K210089 | Fresenius Kabi AG |
| Bad Homburg | 61346 | |
| K973378 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K031554 | GENZYME BIOSURGERY |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K982712 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K960734 | HAEMOCELL PLC |
12 NAPIER COURT | ABINGDON, OXON, ENGLAND | 0X14 3YT | |
| K120586 | HAEMONETICS CORP. |
4925 Robert J Mathews Pkwy Ste 100 | EL DORADO HILLS | CA | 95762 |
| K043127 | HAEMONETICS CORP. |
400 WOOD RD. | BRAINTREE | MA | 02184 |
| K053000 | HAEMONETICS CORP. |
400 WOOD ROAD | BRAINTREE | MA | 02184-9114 |
| K014083 | HAEMONETICS CORP. |
400 WOOD RD. | BRAINTREE | MA | 02184 |
| K101907 | HAEMONETICS CORP. |
400 WOOD RD. | BRAINTREE | MA | 02184 |
| K993581 | HAEMONETICS CORP. |
400 WOOD RD. | BRAINTREE | MA | 02184 |
| K122262 | HAEMONETICS CORP. |
4925 Robert J Mathews Pkwy Ste 100 | EL DORADO HILLS | CA | 95762 |
| K160197 | Haemonetics Corporation |
400 WOOD ROAD | BRAINTREE | MA | 02184 |
| K162423 | HAEMONETICS CORPORATION |
400 WOOD ROAD | BRAINTREE | MA | 02184 |
| K221722 | Haemonetics Corporation |
125 Summer Street | Boston | MA | 02110 |
| K983022 | HARVEST TECHNOLOGIES, LLC. |
77 ACCORD PARK DR. D-7 | NORWELL | MA | 02061 |
| K210176 | Inari Medical |
9 Parker, Suite 100 | Irvine | CA | 92618 |
| K221483 | Inari Medical, Inc. |
6001 Oak Canyon, Suite 100 | Irvine | CA | 92618 |
| K231782 | Inari Medical, Inc. |
6001 Oak Canyon, Suite 100 | Irvine | CA | 92618 |
| K240426 | Inquis Medical |
127 Independence Drive | Menlo Park | CA | 94025 |
| K022348 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K012406 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K942844 | LEVEL 1 TECHNOLOGIES, INC. |
160 WEYMOUTH ST. | ROCKLAND | MA | 02370 |
| K082923 | LIFE-TECH, INC. |
4235 GREENBRIAR DR. | STAFFORD | TX | 77477-3995 |
| K972894 | MEDTRONIC BLOOD MANAGEMENT |
18501 EAST PLAZA DR. | PARKER | CO | 80134-9061 |
| K982755 | MEDTRONIC BLOOD MANAGEMENT |
18501 EAST PLAZA DR. | PARKER | CO | 80134-9061 |
| K093535 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K181954 | MEDTRONIC PERFUSION SYSTEMS |
7611 Northland Drive | Brooklyn Park | MN | 55428 |
| K953118 | MEDTRONIC VASCULAR |
18501 EAST PLAZA DR. | PARKER | CO | 80134-9061 |
| K022167 | PALL CORP. |
2200 NORTHERN BLVD. | EAST HILLS | NY | 11548 |
| K193361 | ProCell Surgical, Inc. |
19 Menin Rd | Toronto | M6C 3J1 | |
| K210862 | Sisu Global Health |
2720 Sisson Street | Baltimore | MD | 21211 |
| K963758 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92614-5751 |
| K963759 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92713-9503 |
| K131553 | SORIN GROUP DEUTSCHLAND GMBH |
195 WEST STREET | WALTHAM | MA | 02451 |
| K112245 | SORIN GROUP ITALIA S.R.L |
PAREXEL CONSULTING | WALTHAM | MA | 02451 |
| K103202 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K101586 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K240584 | Sorin group Italia S.r.l. |
Via Statale 12 Nord, 86 | Mirandola (Modena) | 41037 | |
| K241236 | Sorin Group Italia S.r.l. |
Via Statale 12 Nord, 86 | Mirandola (Modena) | 41037 | |
| K110782 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K970714 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K024097 | SUMMIT MEDICAL LTD. |
BUSINESS & TECHNOLOGY CENTRE | STEVENAGE HERTFORDSHIRE | SGI 2DX | |
| K022489 | SUMMIT MEDICAL LTD. |
BUSINESS & TECHNOLOGY CENTRE | STEVENAGE HERTFORDSHIRE | SGI 2DX | |
| K140197 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K140205 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K130043 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K120953 | TLELFLEX MEDICAL, INC. |
2917 Weck Drive | Research Triangle Park | NC | 27709 |
| K962475 | TRANSFUSION TECHNOLOGIES CORP. |
9 ERIE DR. | NATICK | MA | 01760 |
| K982660 | TRANSFUSION TECHNOLOGIES CORP. |
9 ERIE DR. | NATICK | MA | 01760 |
| K992723 | TRANSFUSION TECHNOLOGIES CORP. |
9 ERIE DR. | NATICK | MA | 01760 |
| K041525 | ZIMMER, INC. |
PO BOX 10 200 W. OHIO AVENUE | DOVER | OH | 44622-0010 |
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