FDA 510(k) Applications for Medical Device:
Unit, Cryosurgical, Accessories
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103310 | 3JT ENTERPRISES LLC |
2000 N. RACINE AVE | CHICAGO | IL | 60614 |
| K072883 | ARBEL MEDICAL LTD. |
990 WASHINGTON ST. | DEDHAM | MA | 02026 |
| K190356 | Arrinex, Inc |
127 Independence drive | Menlo Park | CA | 94025 |
| K160669 | ARRINEX, INC. |
1755 EAST BAYSHORE RD, STE 26 | REDWOOD CITY | CA | 94063 |
| K162608 | ARRINEX, INC. |
1755 EAST BAYSHORE RD, STE 26 | REDWOOD CITY | CA | 94063 |
| K152337 | ATRICURE, INC |
6217 CENTRE PARK DR | WEST CHESTER | OH | 45069 |
| K111042 | ATRICURE, INC. |
6217 CENTRE PARK DRIVE | WEST CHESTER | OH | 45069 |
| K112072 | ATRICURE, INC. |
6217 CENTRE PARK DRIVE | WEST CHESTER | OH | 45069 |
| K140058 | ATRICURE, INC. |
6217 CENTRE PARK DRIVE | WEST CHESTER | OH | 45069 |
| K121507 | ATRICURE, INC. |
6217 CENTRE PARK DRIVE | WEST CHESTER | OH | 45069 |
| K082074 | ATRICURE, INC. |
6033 SCHUMACHER PARK DR. | WEST CHESTER | OH | 45069 |
| K180137 | AtriCure, Inc. |
7555 Innovation Way | Mason | OH | 45040 |
| K142441 | ATRICURE, INC. |
6217 CENTER PARK DRIVE | WEST CHESTER | OH | 45069 |
| K182392 | B.M. Tech. Worldwide Co., Ltd. |
#609, 808, 1001~1007, Jungang lnduspia 5-cha, 137, | Seongnam-si | 13202 | |
| K221897 | BIBAWO Medical A/S |
Klinteh°j Vµnge 6 | Birker°d | 3460 | |
| K964047 | BIODERMIS CORP. |
3753 HOWARD HUGHES PARKWAY, | LAS VEGAS | NV | 89109 |
| K961219 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K230551 | Boston Scientific Corporation |
One Scimed Place | Maple Grove | MN | 55311-1566 |
| K180211 | Bovie Medical Corp. |
5115 Ulmerton Road | Clearwater | FL | 33760 |
| K072453 | BRYMILL CORP. |
105 WINDERMERE AVE., BLDG. 2 | ELLINGTON | CT | 06029 |
| K193619 | Brymill Cryogenic Systems |
105 Windermere Avenue, Suite 2B | Ellington | CT | 06029 |
| K101825 | C2 THERAPEUTICS |
303 CONVENTION WAY | REDWOOD CITY | CA | 94063 |
| K131523 | C2 THERAPEUTICS |
303 CONVENTION WAY | REDWOOD CITY | CA | 94063 |
| K161202 | C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 | Redwood City | CA | 94063 |
| K163684 | C2 Therapeutics, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K160994 | C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 | Redwood City | CA | 94063 |
| K152329 | C2 Therapeutics, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K153541 | C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 | REDWOOD CITY | CA | 94063 |
| K151054 | C2 Therapeutics, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K954872 | CANDELA LASER CORP. |
530 BOSTON POST RD. | WAYLAND | MA | 01778 |
| K955011 | CANDELA LASER CORP. |
555 THIRTEENTH STREET, N.W | WASHINGTON | DC | 20004-1109 |
| K021387 | CHEK-MED SYSTEMS |
25 VILLAGE HILL RD. | WILLINGTON | CT | 06279 |
| K041783 | CHEK-MED SYSTEMS |
25 VILLAGE HILL RD. | WILLINGTON | CT | 06279 |
| K012214 | CIMEX BIOTECH, LLC. |
72385 INDUSTRY PARK | COVINGTON | LA | 70435 |
| K161296 | COOL RENEWAL, LLC |
2515 EUGENIA AVENUE, SUITE 103 | NASHVILLE | TN | 37211 |
| K982280 | CORTEX TECHNOLOGY APS |
1050 CONNECTICUT AVENUE NW | WASHINGTON | DC | 20036-5339 |
| K172049 | Cry IQ AB |
Apelrodsvagen 1 | Onsala | 43932 | |
| K040809 | CRYMED TECHNOLOGIES, INC. |
319 W. TIMONIUM RD. | LUTHERVILLE | MD | 21093 |
| K060555 | CRYMED TECHNOLOGIES, INC. |
3225 ELLERSLIE AVE. | BALTIMORE | MD | 21218 |
| K030303 | CRYOCATH TECHNOLOGIES, INC. |
16771 CHEMIN STE MARIE | KIRKLAND | H9H 5H3 | |
| K190407 | CryoConcepts LP |
205 Webster St | Bethlehem | PA | 18015 |
| K172769 | CryoConcepts LP |
205 Webster Street | Bethlehem | PA | 18015 |
| K183601 | CryoConcepts LP |
205 Webster Street | Bethlehem | PA | 18015 |
| K211099 | CryoConcepts LP |
205 Webster St | Bethlehem | PA | 18015 |
| K170810 | CRYOFOS Medical Gmbh |
Lammstrasse 21 | Karlsruhe | 76133 | |
| K964971 | CRYOGEN, INC. |
6199 CORNERSTONE COURT EAST | SAN DIEGO | CA | 92121 |
| K972662 | CRYOGEN, INC. |
6199 CORNERSTONE COURT EAST | SAN DIEGO | CA | 92121 |
| K982055 | CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K964336 | CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K980670 | CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K980668 | CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K970995 | CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K011073 | CRYOMEDICAL SCIENCES, INC. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K110754 | CRYOPEN, INC. |
577 COMMERCE ST | SOUTHLAKE | TX | 76092 |
| K982506 | CRYOSURGERY, INC. |
P.O. BOX 50035 | NASHVILLE | TN | 37205-0035 |
| K955083 | CRYOSURGERY, INC. |
P.O.BOX 50035 | NASHVILLE | TN | 37205-0035 |
| K160273 | CSA MEDIAL, INC. |
91 HARTWELL AVENUE | LEXINGTON | MA | 02421 |
| K072651 | CSA MEDICAL, INC. |
1101 E. 33RD STREET | BALTIMORE | MD | 21218 |
| K070893 | CSA MEDICAL, INC. |
1101 E. 33RD STREET | BALTIMORE | MD | 21218 |
| K171522 | CSA Medical, Inc. |
91 Hartwell Avenue | Lexington | MA | 02421 |
| K133258 | CSA MEDICAL, INC. |
91 HARTWELL AVE | LEXINGTON | MA | 02421 |
| K143625 | CSA MEDICAL, INC. |
91 HARTWELL AVE | LEXINGTON | MA | 02421 |
| K150920 | CSA MEDICAL, INC. |
91 HARTWELL AVE | LEXINGTON | MA | 02421 |
| K152668 | CSA MEDICAL, INC. |
91 HARTWELL AVE | LEXINGTON | MA | 02421 |
| K161557 | CSA MEDICAL, INC. |
91 HARTWELL AVENUE | LEXINGTON | MA | 02421 |
| K162695 | CSA MEDICAL, INC. |
91 HARTWELL AVENUE | LEXINGTON | MA | 02421 |
| K163244 | CSA MEDICAL, INC. |
91 HARTWELL AVENUE | LEXINGTON | MA | 02421 |
| K171626 | CSA Medical, Inc. |
91 Hartwell Avenue | Lexington | MA | 02421 |
| K172041 | CSA Medical, Inc. |
91 Hartwell Avenue | Lexington | MA | 02421 |
| K113021 | CSA MEDICAL, INC. |
1447 York Rd Ste 610 | Lutherville | MD | 21093 |
| K201183 | CSA Medical, Inc. |
91 Hartwell Ave | Lexington | MA | 02421 |
| K971216 | DERMATOLOGIC LAB & SUPPLY, INC. |
608 13TH AVE. | COUNCIL BLUFFS | IA | 51501 |
| K190747 | DGI Technologies |
500 River Ave | Lakewood | NJ | 08701 |
| K222356 | DGI Technologies |
400 Candlewood Commons | Howell | NJ | 07731 |
| K954703 | ELLMAN INTL., INC. |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K062175 | ENDOCARE, INC. |
201 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K032333 | ENDOCARE, INC. |
201 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K060279 | ENDOCARE, INC. |
201 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K101333 | ENDOCARE, INC. |
9825 SPECTRUM DRIVE | AUSTIN | TX | 78717 |
| K003811 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K011074 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K023757 | ENDOCARE, INC. |
201 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K963826 | ENDOCARE, INC. |
18 TECHNOLOGY DR., SUITE 134 | IRVINE | CA | 92718 |
| K973686 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K963970 | ENDOCARE, INC. |
18 TECHNOLOGY DR., SUITE 134 | IRVINE | CA | 92718 |
| K980110 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K050347 | ENDOCARE, INC. |
201 TECHNOLOGY DR. | IRVINE | CA | 92618 |
| K002615 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K190651 | Erbe Elektromedizin GmbH |
Waldhoernlestrasse 17 | Tuebingen | 72072 | |
| K051509 | ERBE USA, INC. |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K151041 | ERBE USA, INC. |
2225 NORTHWEST PARKWAY | MARIETTA | GA | 30067 |
| K060928 | ETGAR GROUP H.M.Y.A. LTD. |
37A ROTHSCHILD ST., 44449 | KFAR-SABA | ||
| K111859 | GALIL MEDICAL INC. |
63 CHICORY CT. | LAKE JACKSON | TX | 77566 |
| K181153 | Galil Medical Inc. |
4364 Round Lake Road | Arden Hills | MN | 55112 |
| K203032 | Galil Medical Inc. |
4634 Round Lake Rd W | Arden Hills | MN | 55112 |
| K113860 | GALIL MEDICAL INC. |
63 CHICORY CT. | LAKE JACKSON | TX | 77566 |
| K123865 | GALIL MEDICAL INC. |
6518 TAMARIND SKY LN | FULSHEAR | TX | 77441 |
| K143564 | GALIL MEDICAL INC. |
4264 Round Lake Road | Arden Hills | MN | 55112 |
| K173037 | Galil Medical Inc. |
4364 Round Lake Road | Arden Hills | MN | 55112 |
| K152133 | GALIL MEDICAL LTD |
TAVOR 1 BUILDING | SHAAR YOKNEAM | 20692 | |
| K993965 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K991517 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K012497 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K991272 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K162599 | GALIL MEDICAL LTD. |
TAVOR 1 BUILDING, INDUSTRIAL PARK, | SHAAR YOKNEAM | 2069203 | |
| K140584 | GALIL MEDICAL LTD. |
4364 Round Lake Road | Arden Hills | MN | 55112 |
| K121251 | GALIL MEDICAL LTD. |
126 MESQUITE STREET | LAKE JACKSON | TX | 77566 |
| K110946 | GALIL MEDICAL LTD. |
YOKNEAM GATE, 1 TAVOR BLDG. | YOKNEAM | 20692 | |
| K141485 | GALIL MEDICAL LTD. |
4364 Round Lake Road | Arden Hills | MN | 55112 |
| K181741 | Galil Medical Ltd. |
Tavor 1 Building, Industrial Park, PO Box 224 | Yokneam | 2069203 | |
| K070482 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K051052 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K042667 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K031117 | GALIL MEDICAL LTD. |
YOKNEAM GATE, 1 TAVOR BLDG. | YOKNEAM | 20692 | |
| K021261 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K003065 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K011950 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K010991 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K060390 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K052530 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K060144 | GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K024009 | H&O EQUIPMENTS NV/SA |
4655 KIRKWOOD CT. | BOULDER | CO | 80301 |
| K161615 | H&O EQUIPMENTS, NV/SA |
RUE DES JOURNALIERS 1 | Ghislenghien | 7822 | |
| K153489 | Health Tronics |
9825 Spectrum Dr. | Austin | TX | 78717 |
| K141110 | HEALTHTRONICS |
9825 SPECTRUM DR, BLDG 3 | AUSTIN | TX | 78717-4930 |
| K151968 | HEALTHTRONICS |
9825 SPECTRUM DRIVE BUILDING 2 | AUSTIN | TX | 78717 |
| K102360 | ICECURE MEDICAL LTD. |
HAESHEL 7 | CAESARIA | 38900 | |
| K183213 | IceCure Medical LTD. |
7 Haeshel St., P.O. Box 3163 | Caesarea | 3088900 | |
| K991792 | INFLUENCE, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004 |
| K991122 | INFLUENCE, INC. |
71 STEVENSON ST., SUITE 1120 | SAN FRANCISCO | CA | 94105 |
| K152203 | KONINKLIJKE (ROYAL) UTERMOHLEN |
DEE OVERWEG 1 | WOLVEGA | 8471ZA | |
| K130599 | KONINKLIJKE UTERMOHLEN NV |
11956 BERNARDO PLAZA DR. | SAN DIEGO | CA | 92128-1317 |
| K101049 | KONINKLIJKE UTERMOHLEN NV |
4 INNOVATION DRIVE | DUNDAS, ONTARIO | L9H 7P3 | |
| K201740 | MediLink A/S |
Gammelmosevej 176A | Kgs. Lyngby | 2800 | |
| K172373 | Medtech Products Inc. |
660 White Plains Rd | Tarrytown | NY | 10591 |
| K161294 | MEDTECH PRODUCTS INC. |
660 WHITE PLAINS ROAD | Tarrytown | NY | 10591 |
| K083493 | MYOSCIENCE INC |
525 CHESAPEAKE DRIVE | REDWOOD CITY | CA | 94063 |
| K091721 | NEW MEDICAL TECHNOLOGIES GMBH |
1710 ROMANO DRIVE | PLYMOUTH MEETING | PA | 19462 |
| K161337 | NUANCE MEDICAL, LLC |
5931 Sea Lion Place, Suite 113 | Carlsbad | CA | 92008 |
| K210310 | Nuance Medical, LLC |
5931 Sea Lion Place, Suite 113 | Carlsbad | CA | 82010 |
| K130995 | NUANCE MEDICAL, LLC |
300 CARLSBAD VILLAGE DRIVE, SUITE 108 | CARLSBAD | CA | 92008 |
| K060859 | ORASURE TECHNOLOGIES, INC. |
150 WEBSTER ST. | BETHELEHEM | PA | 18015-1389 |
| K982358 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K990877 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K971392 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K023487 | ORASURE TECHNOLOGIES, INC. |
150 WEBSTER ST. | BETHELEHEM | PA | 18015-1389 |
| K980739 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K190194 | PENTAX Medical, A Division of PENTAX of America, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K212814 | PENTAX of America, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K203024 | PENTAX of America, Inc. |
303 Convention Way, Suite 1 | Redwood, CA | CA | 94063 |
| K970992 | PREMIER DENTAL PRODUCTS CO. |
3600 HORIZON DR. | KING OF PRUSSIA | PA | 19406 |
| K201366 | Pronova Laboratories BV |
Kruitpad 16 | Muiden | 1398 CP | |
| K161480 | R2 Dermatology |
Bishop Ranch 3 2633 Camino Ramon | San Ramon | CA | 94583 |
| K171398 | R2 Dermatology ,Inc |
2633 Camino Ramon, Suite 130 | San Ramon | CA | 94583 |
| K201260 | R2 Technologies, Inc. |
2603 Camino Ramon, Suite 200 | San Ramon | CA | 94583 |
| K203481 | Recens Medical Inc. |
908, SK V1 center, 830 Dongtansunhwan-daero | Hwaseong-si | 18468 | |
| K220674 | RecensMedical Inc. |
908, SK V1 center, 830 Dongtansunhwan-daero | Hwaseong-si | 18468 | |
| K221234 | RecensMedical Inc. |
908, SK V1 center, 830 Dongtansunhwan-daero | Hwaseong-si | 18468 | |
| K230599 | RecensMedical, Inc. |
#507, #908, SK V1 center, 830 Dongtansunhwan-daero | Hwaseong-si | 18468 | |
| K021211 | SANARUS MEDICAL, INC. |
5880 WEST LAS POSITAS,SUITE 52 | PLEASANTON | CA | 94588 |
| K052861 | SANARUS MEDICAL, INC. |
4696 WILLOW RD. | PLEASANTON | CA | 94588 |
| K073533 | SANARUS MEDICAL, INC. |
4696 WILLOW RD. | PLEASANTON | CA | 94588 |
| K061510 | SANARUS MEDICAL, INC. |
4696 WILLOW RD. | PLEASANTON | CA | 94588 |
| K020605 | SANARUS MEDICAL, INC. |
5880 WEST LAS POSITAS,SUITE 52 | PLEASANTON | CA | 94588 |
| K022314 | SANARUS MEDICAL, INC. |
5880 WEST LAS POSITAS,SUITE 52 | PLEASANTON | CA | 94588 |
| K062896 | SANARUS MEDICAL, INC. |
4696 WILLOW RD. | PLEASANTON | CA | 94588 |
| K052259 | SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. |
3 CONNELL DR. | BERKELEY HEIGHTS | NJ | 07922-0603 |
| K031697 | SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. |
3 CONNELL DR. | BERKELEY HEIGHTS | NJ | 07922-0603 |
| K102006 | STC CONSULTING LLC |
4093 MAULFAIR DRIVE | ALLENTOWN | PA | 18103 |
| K222272 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K223369 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K210529 | The OTC Lab Healthcare B.V. |
Fred. Roeskestraat 115 | Amsterdam | 1076EE | |
| K090978 | UC-CARE LTD. |
555 THIRTEENTH STREET NW | WASHINGTON | DC | 20004 |
| K960387 | UROS CORP. |
1668 LOS ALTOS RD. | SAN DIEGO | CA | 92109 |
| K201588 | Varian Medical Systems, Inc. |
3100 Hansen Way | Palo Alto | CA | 94304 |
| K230271 | Varian Medical Systems, Inc. |
3100 Hansen Way | Palo Alto | CA | 94304-1038 |
| K211149 | Varian Medical Systems, Inc. |
9825 Spectrum Drive, Building 2, Suite 250 | Austin | TX | 78717 |
| K011708 | WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. | BRAMPTON, ONTARIO | L6T 3Z8 | |
| K030838 | WARTNER MEDICAL PRODUCTS |
65 AVA CRESCENT | RICHMOND HILL, ONTARIO | L4B 2X5 | |
| K002714 | WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. | BRAMPTON, ONTARIO | L6T 3Z8 | |
| K032271 | WARTNER USA B.V. |
65 AVA CRESCENT | RICHMOND HILL, ONTARIO | L4B 2X5 | |
| K140314 | YONMEDICAL BV |
PO BOX 2042 | FAIRFIELD | IA | 52556 |
| K151309 | YOUMEDICAL CORP BV |
RIJNSBURGSTRAAT 9-11 | AMSTERDAM | 1059 AT | |
| K193665 | Yozma BmTech Co., Ltd. |
#609, 808, 1001~1007, Jungang Induspia 5-cha, 137, | Seongnam-si | 13202 |
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