FDA 510(k) Applications for Medical Device:
Warmer, Thermal, Infusion Fluid
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K122449 | ACACIA, INC. |
785 CHALLENGER ST. | BREA | CA | 92821 |
| K060939 | ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. | EDEN PRAIRIE | MN | 55344 |
| K082217 | ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. | EDEN PRAIRIE | MN | 55344 |
| K023653 | AUTOMATIC MEDICAL TECHNOLOGIES, INC. |
1711 NORTH BUSH ST. | SANTA ANA | CA | 92706 |
| K002409 | AUTOMATIC MEDICAL TECHNOLOGIES, INC. |
3422 WEST PICO BLVD. | LOS ANGELES | CA | 90019 |
| K213191 | Barkey GmbH & Co. KG |
Gewerbestr. 8 | Leopoldshoehe | 33818 | |
| K032674 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K090089 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K131519 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K070654 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K032778 | BELMONT INSTRUMENT CORP. |
780 BOSTON RD. | BILLERICA | MA | 01821 |
| K152208 | BELMONT INSTRUMENT CORPORATION |
780 BOSTON ROAD | BILLERICA | MA | 01821 |
| K121198 | BIEGLER GMBH |
24301 WOODSAGE DR | BONITA SPRINGS | FL | 34134 |
| K954769 | BIEGLER MEDICAL PRODUCTS, INC. |
7 IRIS COURT | CARLISLE, ONTARIO | L0R 1H0 | |
| K955659 | C.F. ELECTRONICS, INC. |
5 BRAYTON COURT | COMMACK | NY | 11725 |
| K150484 | Creche Innovations |
17745 Metcalf | Stilwell | KS | 66085 |
| K012906 | ELLTEC CO., LTD. |
SHIRAKAWA NO. 6 BLDG. | NAGOYA | 460-0003 | |
| K024373 | ELLTEC CO., LTD. |
SHIRAKAWA NO. 6 BLDG. | NAGOYA | 460-0003 | |
| K103801 | EMIT CORPORATION |
42 NORTH CHATSONG CIRCLE | WOODLANDS | TX | 77382 |
| K060537 | ENGINIVITY LLC |
8 GRAY LODGE ROAD | KITTERY | ME | 03904 |
| K132202 | ENTHERMICS MEDICAL SYSTEMS, INC. |
WEST 164 NORTH 9221 WATER ST. | MENOMONEE FALLS | WI | 53051 |
| K091336 | ENTHERMICS MEDICAL SYSTEMS, INC. |
1601 K STREET NW | WASHINGTON | DC | 20006 |
| K102900 | HEI, INC. |
4801 NORTH 63RD. ST. | BOULDER | CO | 80301 |
| K112702 | IMPERIAL SURGICAL LTD. |
4 INNOVATION DRIVE | DUNDAS | L9H 7P3 | |
| K192325 | Life Warmer, Inc. |
4813 Keller Springs Rd | Addison | TX | 75001 |
| K181775 | Life Warmer, Inc. |
840 F. Avenue Suite 104 | Plano | TX | 75074 |
| K180842 | MAC Medical Inc. |
820 S Mulberry | Millstadt | IL | 62260 |
| K981509 | MEDICAL PRODUCTS, INC. |
14014 SULLYFIELD CIRCLE, #A | CHANTILLY | VA | 20151 |
| K120860 | MEDICAL RESCUE EQUIPMENT HOLDING AS |
POSTBOKS 186 | Porsgrunn | 3901 | |
| K041839 | MEDICAL SOLUTIONS, INC. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K980086 | MEDICAL SOLUTIONS, INC. |
P.O BOX 4343 | CROFTON | MD | 21114 |
| K012276 | MEDICAL SOLUTIONS, INC. |
3901 CENTERVIEW DR., SUITE W | CHANTILLY | VA | 20151 |
| K062644 | MERLYN ASSOCIATES, INC. |
1542 EDINGER AVE., SUITE A | TUSTIN | CA | 92780 |
| K031390 | MINIMED, INC. |
18000 DEVONSHIRE ST. | NORTHRIDGE | CA | 91325 |
| K132110 | NATUS NICOLET IRELAND LTD |
IDA BUSINESS PARK | GORT, COUNTY GALWAY | IE | |
| K012832 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K073363 | PALADIN BIOMEDICAL CORPORATION |
506 BOSTON POST ROAD | WESTON | MA | 02493 |
| K150404 | Quality in Flow Ltd. |
3A Bazel St. POB 10159 | Petach Tikva | 49002 | |
| K163708 | Quality In Flow Ltd. |
Kibutz Einat POB 29 | Kibutz Einat | 4880500 | |
| K171215 | Quality In Flow Ltd. |
Kibutz Einat POB 29 | Kibutz Einat | 4880500 | |
| K180154 | Quality In Flow Ltd. |
Kibutz Einat POB 29 | Kibutz Einat | 4880500 | |
| K211800 | Quality in Flow Ltd. |
11 HaÆavoda st. | Rosh HaÆayin | 4801761 | |
| K161613 | RanD S.r.l. |
via Statale 12, 62 | Medolla | 41036 | |
| K120026 | RAND S.R.L. |
VIA STATALE 12,62 | MEDOLLA, (MO) | 41036 | |
| K001764 | SIMS LEVEL 1, INC. |
160 WEYMOUTH ST. | ROCKLAND | MA | 02370 |
| K052055 | SMISSON-CARTLEDGE BIOMEDICAL LLC |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K202461 | Smisson-Cartledge Biomedical LLC |
487 Cherry Street - Third Street Tower | Macon | GA | 31201 |
| K973748 | SMITH |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K072080 | SMITHS MEDICAL ASD, INC. |
160 WEYMOUTH ST. | ROCKLAND | MA | 02370 |
| K110769 | STERIS Corporation |
5960 HEISLEY | MENTOR | OH | 44060 |
| K092823 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K111870 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K082765 | STIHLER ELECTRONIC GMBH |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K060851 | THE SMITHWORKS COMPANY |
2615 102ND AVE NE | BELLEVUE | WA | 98004 |
| K211618 | The Surgical Company International B.V. |
Beeldschermweg 6F | Amersfoort | 3821 AH | |
| K092366 | THERMAL THERAPEUTIC SYSTEMS, INC |
PO BOX 961 | MOON TOWNSHIP | PA | 15108 |
| K112902 | VITAL SIGNS, INC. |
20 CAMPUS RD. | TOTOWA | NJ | 07512 |
| K130867 | VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
20 CAMPUS RD | TOTOWA | NJ | 07512 |
| K121775 | VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
20 CAMPUS RD | TOTOWA | NJ | 07512 |
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