FDA 510(k) Applications for Medical Device:
Clip, Implantable
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K230966 |
A2 Medical Systems, LLC |
6387 Technology Ave.
| Kalamazoo |
MI |
49009 |
K220006 |
A2 Medical Systems, LLC |
6387 Technology Ave.
| Kalamazoo |
MI |
49009 |
K051125 |
ABBOTT LABORATORIES |
400 Saginaw Drive
| Redwood City |
CA |
94063 |
K111930 |
ACKERMANN INSTRUMENTE GMBH |
8202 SHERMAN ROAD
| CHESTERLAND |
OH |
44026-2141 |
K030926 |
ADVANCED SURGICAL PRODUCTS, INC. |
681 MANZANITA AVE.
| SUNNYVALE |
CA |
94085 |
K202124 |
Aesculap Inc. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
K080753 |
AESCULAP, INC. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
K081031 |
AESCULAP, INC. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
K102081 |
AESCULAP, INC. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
K012342 |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST
| MINNETONKA |
MN |
55343 |
K172479 |
Amsel Medical |
171 Hamilton Street
| Cambridge |
MA |
02139 |
K180650 |
Amsel Medical Corporation |
171 Hamilton Street
| Cambridge |
MA |
02139 |
K140932 |
AMSEL MEDICAL CORPORATION |
93 BENEFIT STREET
| PROVIDENCE |
RI |
02904 |
K032896 |
ANSON MEDICAL LTD. |
67 MILTON PARK
| ABINGDON, OXFORDSHIRE |
|
OX14 4RX |
K964470 |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE
| LAGUNA HILLS |
CA |
92653 |
K993135 |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE
| LAGUNA HILLS |
CA |
92653 |
K011236 |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa
| Rancho Santa Margarita |
CA |
92688 |
K033024 |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa
| Rancho Santa Margarita |
CA |
92688 |
K032217 |
ARTEMIS MEDICAL, INC. |
21021 CORSAIR BLVD.
| HAYWARD |
CA |
94545 |
K003777 |
ARTEMIS MEDICAL, INC. |
655 MARINERS ISLAND BLVD.
| SAN MATEO |
CA |
94404 |
K163261 |
ATRICURE INC. |
7555 Innovation Way
| Mason |
OH |
45040 |
K180010 |
AtriCure, Inc. |
7555 Innovation Way
| Mason |
OH |
45040 |
K131107 |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K122276 |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K142120 |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K150996 |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K160454 |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K172742 |
AtriCure, Inc. |
7555 Innovation Way
| Mason |
OH |
45040 |
K093679 |
ATRICURE, INC. |
6217 CENTER PARK DRIVE
| WEST CHESTER |
OH |
45069 |
K153500 |
Atricure, Inc. |
6217 Centre Park Drive
| West Chester |
OH |
45069 |
K173031 |
AtriCure, Inc. |
7555 Innovation Way
| Mason |
OH |
45040 |
K033979 |
BY-PASS MAKAFIM LTD. |
555 13TH ST. NW
| WASHINGTON |
DC |
20004-1109 |
K020470 |
BYPASS LTD. |
555 THIRTEENTH ST. NW
| WASHINGTON |
DC |
20004-1109 |
K040832 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K053524 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K070548 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K073123 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K073304 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K063644 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K101018 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K081225 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K091017 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K090872 |
CARDICA, INC. |
900 SAGINAW DR.
| REDWOOD CITY |
CA |
94063 |
K994160 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K012317 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K021407 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K024366 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K040821 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K003958 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K031623 |
COALESCENT SURGICAL |
559 EAST WEDDELL DR.
| SUNNYVALE |
CA |
94089 |
K150936 |
CONMED CORPORATION |
525 FRENCH ROAD
| UTICA |
NY |
13502 |
K121194 |
COVIDIEN |
60 MIDDLETOWN AVE.
| NORTH HAVEN |
CT |
06473 |
K142869 |
COVIDIEN |
60 Middletown Avenue
| North Haven |
CT |
06473 |
K143644 |
COVIDIEN |
60 Middletown Ave
| North Haven |
CT |
06473 |
K143598 |
Covidien LLC |
60 Middletown Ave
| North Haven |
CT |
06473 |
K192711 |
Dannik |
941 W Morse Blvd. Suite 100
| Winter Park |
FL |
32789 |
K981239 |
DEROYAL SURGICAL |
185 RICHARDSON WAY
| MAYNARDVILLE |
TN |
37807 |
K040602 |
DESIGN STANDARDS CORP. |
182 CEDA RD.
| CHARLESTOWN |
NH |
03603 |
K971588 |
ELECTIVE VASCULAR INTERVENTION INC. (EVI) |
2108 BLACKWOOD DR.
| WALNUT CREEK |
CA |
94596 |
K050344 |
ETHICON ENDO SURGERY, INC. |
4545 CREEK ROAD
| CINCINNATI |
OH |
45242 |
K232313 |
Ethicon Endo Surgery, LLC. |
475 Calle C
| Guaynabo |
|
00969 |
K110699 |
ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD.
| CINCINNATI |
OH |
45242 |
K150840 |
ETHICON ENDO-SURGERY, LLC |
475 CALLE C SUITE 202
| GUAYNABO |
PR |
00969 |
K181488 |
Ethicon Endo-Surgery, LLC |
475 Calle C Suite 202
| Guynabo |
PR |
00969 |
K100090 |
GENICON |
6869 STAPOINT CT., SUITE 114
| WINTER PARK |
FL |
32792 |
K030269 |
GENICON, LC |
P.O. BOX 780038
| ORLANDO |
FL |
32878-0038 |
K033161 |
GYRX, LLC |
11222 ST. JOHNS INDUSTRIAL
| JACKSONVILLE |
FL |
32246 |
K981631 |
INFLUENCE, INC. |
555 THIRTEENTH STREET, N.W.
| WASHINGTON |
DC |
20004 |
K020879 |
INTEGRATED VASCULAR SYSTEMS, INC. |
743 NORTH PASTORIA AVE.
| SUNNYVALE |
CA |
94085 |
K953258 |
INTRAMED LABORATORIES, INC. |
11100 ROSELLE ST.
| SAN DIEGO |
CA |
92121 |
K173323 |
LeMaitre Vascular, Inc. |
63 Second Ave.
| Burlington |
MA |
01803 |
K091987 |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE
| BURLINGTON |
MA |
01803 |
K200166 |
M/s. Meril Endo Surgery Private Limited |
Third Floor , E1-E3, Meril Park, Survey No. 135/2/B & 174/2,
| Chala, Vapi |
|
396191 |
K072525 |
MEDICINELODGE, INC. |
180 SOUTH 600 WEST
| LOGAN |
UT |
84321 |
K962016 |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE
| MUNDELEIN |
IL |
60060 |
K081082 |
MEDTRONIC INC. |
3051 S. NEWCOMBE WAY
| LAKEWOOD |
CO |
80227 |
K062821 |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR.
| GOLETA |
CA |
93117 |
K062057 |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR.
| MINNEAPOLIS |
MN |
55428 |
K053252 |
MEDTRONIC VASCULAR |
1015 GRAMSIE RD
| SHOREVIEW |
MN |
55126-3082 |
K013264 |
MICRO STAMPING CORP. |
7736 WOODSIDE COURT
| MAINEVILLE |
OH |
45039 |
K964109 |
MICROSURGE, INC. |
150 A ST.
| NEEDHAM |
MA |
02194 |
K053255 |
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
540 COLLEGE STREET
| BELLAIRE |
TX |
77401 |
K052018 |
MILTEX, INC. |
589 DAVIES DRIVE
| YORK |
PA |
17402 |
K151943 |
NANOVA BIOMATERIALS INC |
3806 MOJAVE CT
| COLUMBIA |
MO |
65202 |
K213813 |
NeuraMedica Inc |
402 Beavercreek Road, Suite 110
| Oregon City |
OR |
97045 |
K032238 |
NEUROSEL (MEDICAL) LIMITED |
GREENWAYS
| ANDOVER, HAMPSHIRE |
|
SP11 7BH |
K033324 |
NITI MEDICAL TECHNOLOGIES LTD. |
1 HATZORAN ST.
| NETANYA |
|
42506 |
K041751 |
NITI MEDICAL TECHNOLOGIES LTD. |
1 HATZORAN ST.
| NETANYA |
|
42506 |
K050356 |
NITI MEDICAL TECHNOLOGIES LTD. |
1 HATZORAN ST.
| NETANYA |
|
42506 |
K062008 |
NITI MEDICAL TECHNOLOGIES LTD. |
4 HATZORAN ST.
| NATANYA |
|
42506 |
K043115 |
NITI MEDICAL TECHNOLOGIES LTD. |
1 HATZORAN ST.
| NETANYA |
|
42506 |
K093661 |
NITI SURGICAL SOLUTIONS LTD |
555 THIRTEENTH STREET, NW
| WASHINGTON |
DC |
20004 |
K020054 |
SANARUS MEDICAL, INC. |
5880 WEST LAS POSITAS,SUITE 52
| PLEASANTON |
CA |
94588 |
K973652 |
SCION INTERNATIONAL, INC. |
5200 BLUE LAGOON DRIVE,
| MIAMI |
FL |
33126 |
K011402 |
SENORX, INC. |
11 COLUMBIA, SUITE A
| ALISO VIEJO |
CA |
92656 |
K100242 |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
60 MIDDLETOWN AVE.
| NORTH HAVEN |
CT |
06473 |
K150259 |
TAIWAN SURGICAL CORPORATION |
3F., No. 12. Sec 2, ShengYi Rd.
| Zhubei City |
|
30261 |
K202994 |
Taiwan Surgical Corporation |
3F., No.12, Sec.2, ShengYi Rd.
| Zhubei City |
|
30261 |
K133202 |
TELEFLEX MEDICAL |
2917 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K062914 |
TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD
| BANNOCKBURN |
IL |
60015 |
K132658 |
TELEFLEX MEDICAL |
2917 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K161758 |
TELEFLEX MEDICAL |
3015 CARRINGTON MILL BLVD
| MORRISVILLE |
NC |
27560 |
K230480 |
Teleflex Medical |
3015 Carrington Mill Blvd
| Morrisville |
NC |
27560 |
K152081 |
Teleflex Medical, Inc. |
3015 Carrington Mill Blvd
| Morrisville |
NC |
27560 |
K142777 |
Teleflex Medical, Inc. |
2917 Weck Drive
| Research Triangle Park |
NC |
27709 |
K061288 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K001450 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K962043 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K971201 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K071406 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K970793 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K984438 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K991002 |
V. MUELLER NEURO/SPINE |
360 INDUSTRIAL RD., UNIT H
| SAN CARLOS |
CA |
94070 |
K032980 |
VANGUARD MEDICAL CONCEPTS, INC. |
3706 76TH STREET
| LUBBOCK |
TX |
79423 |
K091060 |
VESOCCLUDE MEDICAL, LLC |
10419 STALLINGS ROAD
| SPRING HOPE |
NC |
27882 |
K152082 |
Vesocclude Medical, LLC |
7429 ACC BLVD
| Raleigh |
NC |
27617 |
K981645 |
VITALITEC INT'L., INC. |
15 CASWELL LN.
| PLYMOUTH |
MA |
02360 |
K000278 |
VIVANT MEDICAL, INC. |
3210-B ALPINE RD.
| PORTOLA VALLEY |
CA |
94028 |
K030311 |
WECK |
2917 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K021808 |
WECK |
2917 WECK DR.
| DURHAM |
NC |
27709 |
K982944 |
WECK CLOSURE SYSTEMS |
ONE WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K982941 |
WECK CLOSURE SYSTEMS |
1 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K993157 |
WECK CLOSURE SYSTEMS |
ONE WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K003337 |
WECK CLOSURE SYSTEMS |
1 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K982313 |
WECK CLOSURE SYSTEMS |
1 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K993424 |
Y-CLIP ASSOCIATES |
116 DEFENSE HIGHWAY
| ANNAPOLIS |
MD |
21401 |
|
|