FDA 510(k) Applications for Medical Device:
Bandage, Liquid
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K053409 |
3M COMPANY |
3M CENTER, BLDG. 275-5W-06
| ST. PAUL |
MN |
55144-1000 |
K031263 |
3M COMPANY |
3M CENTER, BLDG. 275-5W-06
| ST. PAUL |
MN |
55133-3275 |
K982893 |
3M COMPANY |
3M-CENTER
| ST. PAUL |
MN |
55144 |
K982892 |
3M COMPANY |
3M-CENTER
| ST. PAUL |
MN |
55144 |
K153571 |
3M HEALTH CARE |
3M CENTER, 2510 CONWAY AVE.,
| ST.PAUL |
MN |
55144 |
K955103 |
3M MEDICAL PRODUCTS GROUP |
3M CENTER, BLDG. 275-3E-08
| ST. PAUL |
MN |
55144-1000 |
K961452 |
ACME UNITED CORP. |
75 KINGS HWY. CUT-OFF
| FAIRFIELD |
CT |
06430 |
K961323 |
ACME UNITED CORP. |
75 KINGS HWY. CUT-OFF
| FAIRFIELD |
CT |
06430 |
K992032 |
ACRYMED, INC. |
12232 S.W. GARDEN PL.
| PORTLAND |
OR |
97223 |
K963656 |
ADRI |
P.O. BOX 134
| PARK FOREST |
IL |
60466 |
K133443 |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
WESTERN WOOD WAY
| PLYMOUTH, DEVON |
|
PL7 5BG |
K171148 |
Aleo BME Inc. |
200 Innovations Blvd, Ste. 210A
| State College |
PA |
16803 |
K964614 |
AMERICAN WHITE CROSS, INC. |
349 LAKE RD.
| DAYVILLE |
CT |
06241 |
K984207 |
ARGENTUM INTERNATIONAL LLC. |
PO BOX 429
| LAKEMONT |
GA |
30552 |
K953500 |
ASIA DYNAMICS, INC. |
5745 WEST HOWARD ST.
| NILES |
IL |
60714 |
K973227 |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE.
| BETHLEHEM |
PA |
18018 |
K022645 |
BEIERSDORF AG |
49 PLAIN ST.
| NORTH ATTLEBORO |
MA |
02760 |
K073663 |
BIOCURE, INC. |
20310 SW 48TH STREET
| SOUTHWEST RANCHES |
FL |
33332 |
K980451 |
BIODERM, INC. |
P.O. BOX 4882
| WHEATON |
IL |
60189 |
K973429 |
BIODERM, INC. |
25 WEST 752 WHITE BIRCH LN.
| WHEATON |
IL |
60187 |
K982778 |
BIODERM, INC. |
P.O. BOX 4882
| WHEATON |
IL |
60189 |
K963602 |
BIODERM, INC. |
P.O. BOX 4882
| WHEATON |
IL |
60189 |
K990955 |
BIODERM, INC. |
P.O. BOX 4882
| WHEATON |
IL |
60189 |
K980117 |
BIOMEDICAL DEVELOPMENT CO. |
6401 MEADOWS WEST DR.
| FORT WORTH |
TX |
76132 |
K050757 |
CHEMENCE MEDICAL INC. |
185 BLUEGRASS VALLEY PKWY.
| ALPHARETTA |
GA |
30005-2222 |
K083913 |
CHESSON LABORATORY ASSOCIATES, INC. |
3100 TOWER BLVD., SUITE 117
| DURHAM |
NC |
27707 |
K120059 |
CHESSON LABORATORY ASSOCIATES, INC. |
603 ELLIS ROAD
| DURHAM |
NC |
27703 |
K002338 |
CLOSURE MEDICAL CORP. |
5250 GREENS DAIRY RD.
| RALEIGH |
NC |
27616 |
K983519 |
COLOPLAST CORP. |
1955 WEST OAK CIR.
| MARIETTA |
GA |
30062-2249 |
K954728 |
CONTINENTAL MEDICAL LABORATORIES, INC. |
P.O. BOX 306
| WATERFORD |
WI |
53185 |
K982116 |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K972062 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K972530 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K974205 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K980382 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K974823 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K980720 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K042955 |
D & D HOLDINGS, LLC |
10 WYNSTONE
| NASHVILLE |
TN |
37215 |
K963603 |
DERMA SCIENCES, INC. |
121 WEST GRACE ST.
| OLD FORGE |
PA |
18518 |
K970660 |
DERMA SCIENCES, INC. |
15825 SHADY GROVE RD.
| ROCKVILLE |
MD |
20850 |
K991608 |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN.
| ARVADA |
CO |
80005-5306 |
K991933 |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN.
| ARVADA |
CO |
80005-5306 |
K991920 |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN.
| ARVADA |
CO |
80005-5306 |
K991609 |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN.
| ARVADA |
CO |
80005-5306 |
K970600 |
DERMARX CORP. |
400 SOUTH COLORADO BLVD.,#420
| DENVER |
CO |
80222 |
K972336 |
DERMARX CORP. |
400 SOUTH COLORADO BLVD.,#420
| DENVER |
CO |
80222 |
K965120 |
DPT LABORATORIES, LTD. |
100 EAST 15TH ST.
| FORT WORTH |
TX |
76102 |
K980863 |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
104 SHORTING ROAD
| TORONTO, ONTARIO |
|
M1S 3S4 |
K980779 |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
104 SHORTING ROAD
| TORONTO, ONTARIO |
|
M1S 3S4 |
K991694 |
DYNAREX CORP. |
ONE INTERNATIONAL BLVD.
| BREWSTER |
NY |
10509 |
K991695 |
DYNAREX CORP. |
ONE INTERNATIONAL BLVD.
| BREWSTER |
NY |
10509 |
K984539 |
FERRIS MFG. CORP. |
16 WEST 300 83RD ST.
| BURR RIDGE |
IL |
60527 |
K990906 |
FERRIS MFG. CORP. |
16 WEST 300 83RD ST.
| BURR RIDGE |
IL |
60527 |
K991729 |
FERRIS MFG. CORP. |
16 WEST 300 83RD ST.
| BURR RIDGE |
IL |
60527 |
K982818 |
GAMBRO HEALTHCARE |
1185 OAK ST.
| LAKEWOOD |
CO |
80215-4498 |
K030574 |
GLUSTITCH, INC. |
#307 7188 PROGRESS WAY
| DELTA, B.C. |
|
V4G 1M6 |
K083752 |
GLUSTITCH, INC. |
#307 7188 PROGRESS WAY
| DELTA, B.C. |
|
V4G 1M6 |
K040779 |
HOLLISTER, INC. |
2000 HOLLISTER DR.
| LIBERTYVILLE |
IL |
60048 |
K980673 |
INNOVATIVE TECHNOLOGIES (US), INC. |
581 CONFERENCE PLACE
| GOLDEN, |
CO |
80401 |
K980989 |
INNOVATIVE TECHNOLOGIES LTD. |
3M CENTER, BLDG 275-3E-08
| ST PAUL |
MN |
55144-1000 |
K982234 |
INNOVATIVE TECHNOLOGIES LTD. |
ROAD THREE, WINSFORD
| WINSFORD, CHESHIRE |
|
CW7 3PD |
K973283 |
INNOVATIVE TECHNOLOGIES LTD. |
ROAD THREE, WINSFORD
| WINSFORD, CHESHIRE |
|
CW7 3PD |
K963598 |
INNOVATIVE TECHNOLOGIES LTD. |
ROAD THREE, WINSFORD
| WINSFORD, CHESHIRE |
|
CW7 3PD |
K962421 |
INNOVATIVE TECHNOLOGIES LTD. |
ROAD THREE, WINSFORD
| WINSFORD, CHESHIRE |
|
CW7 3PD |
K062602 |
JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
199 GRANDVIEW ROAD
| SKILLMAN |
NJ |
08558-9498 |
K964016 |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD.
| ARLINGTON |
TX |
76004-0130 |
K973509 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST.
| MANSFIELD |
MA |
02048 |
K973619 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST.
| MANSFIELD |
MA |
02048 |
K131384 |
KERICURE INC. |
445 APOLLO BEACH BLVD
| APOLLO BEACH |
FL |
33572 |
K955399 |
LANGE MEDICAL PRODUCTS, INC. |
1676 SOUTH WOLF RD.
| WHEELING |
IL |
60090 |
K092712 |
LODESTAR PRODUCTS, INC. |
6833 SAINT LAWRENCE ST.
| PLANO |
TX |
75024 |
K984177 |
MARINE POLYMER TECHNOLOGIES, INC. |
107 WATER ST.
| DANVERS |
MA |
01923 |
K082703 |
MARINE POLYMER TECHNOLOGIES, INC. |
107 WATER ST.
| DANVERS |
MA |
01923 |
K002550 |
MARINE POLYMER TECHNOLOGIES, INC. |
107 WATER ST.
| DANVERS |
MA |
01923 |
K961662 |
MARINER BIOMEDICAL, INC. |
73 FAULKNER DR.
| GUILFORD |
CT |
06437 |
K013225 |
MEDAFOR, INC. |
5201 EAST RIVER ROAD, # 312
| MINNEAPOLIS |
MN |
55421-1035 |
K962740 |
MEDI-FLEX HOSPITAL PRODUCTS, INC. |
19 BUTTERFIELD TRAIL
| EL PASO |
TX |
79906 |
K031321 |
MEDLOGIC GLOBAL LIMITED |
WESTERN WOOD WAY
| PLYMOUTH, DEVON |
|
PL7 5BG |
K023163 |
MEDLOGIC GLOBAL LIMITED |
WESTERN WOOD WAY
| PLYMOUTH, DEVON |
|
PL7 5BG |
K032948 |
MEDPAK, LLC |
568 PARKSIDE COURT
| ALLENTOWN |
PA |
18104 |
K051082 |
MEDTRADE PRODUCTS LTD. |
ELECTRA HOUSE
| CREWE, CHESHIRE |
|
CW1 6GL |
K983554 |
MOLNLYCKE HEALTH CARE, INC. |
500 BALDWIN TOWER
| EDDYSTONE |
PA |
19022 |
K964231 |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
18 WHITE LAKE RD.
| SPARTA |
NJ |
07871 |
K081009 |
NOVABAY PHARMACEUTICALS |
5980 HORTON ST. SUITE 550
| EMERYVILLE |
CA |
94608 |
K971090 |
OPPORTUNITY, INC. |
1200 OLD SKOKIE RD.
| HIGHLAND PARK |
IL |
60035 |
K971091 |
OPPORTUNITY, INC. |
1200 OLD SKOKIE RD.
| HIGHLAND PARK |
IL |
60035 |
K083087 |
POLICHEM S.A. |
7361 CALHOUN PLACE
| ROCKVILLE |
MD |
20855 |
K063202 |
PROCUREMENT TECHNOLOGY SYSTEMS, LLC |
2375 HIGHWAY 101 SOUTH
| GREER |
SC |
29651 |
K971612 |
PROCYTE CORP. |
12040 115TH AVENUE NE
| KIRKLAND |
WA |
98034-6900 |
K972150 |
PROCYTE CORP. |
P.O. BOX 808
| REDMOND, |
WA |
98073-0808 |
K972329 |
PROCYTE CORP. |
8511 154TH AVE., N.E., BLDG. A
| REDMOND |
WA |
98052 |
K962623 |
PROCYTE CORP. |
12040 115TH AVENUE NE
| KIRKLAND |
WA |
98034 |
K160684 |
ROCHAL INDUSTRIES LLC |
12719 CRANES MILL
| SAN ANTONIO |
TX |
78230 |
K182733 |
Rochal Industries, LLC |
12000 Network Blvd, Ste B200
| San Antonio |
TX |
78249 |
K971337 |
RYNEL LTD, INC. |
ROUTE 27
| BOOTHBAY |
ME |
04537 |
K963096 |
SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD.
| LARGO |
FL |
34649-1970 |
K983210 |
SMITH & NEPHEW, INC. |
11775 STARKEY RD.
| LARGO |
FL |
33773-4727 |
K973228 |
SMITH & NEPHEW, INC. |
11775 STARKEY RD.
| LARGO |
FL |
33773-4727 |
K983833 |
WESTAIM BIOMEDICAL, INC. |
555 THIRTEENTH ST. NW
| WASHINGTON |
DC |
20004 |
K955453 |
WESTAIM TECHNOLOGIES, INC. |
555 13TH STREET, N.W.
| WASHINGTON |
DC |
20004-1109 |
|
|