FDA 510(k) Applications for Medical Device:
Dressing, Wound, Collagen
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K092926 |
ACELL, INC |
8671 ROBERT FULTON DRIVE
| COLUMBIA |
MD |
21046 |
K060888 |
ACELL, INC |
5600 WISCONSIN AVE.
| CHEVY CHASE |
MD |
20815 |
K022854 |
ACELL, INC |
815 CONNECTICUT AVE NW
| WASHINGTON |
DC |
20006 |
K021637 |
ACELL, INC |
815 CONNECTICUT AVE NW
| WASHINGTON |
DC |
20006 |
K152721 |
ACELL, INC |
6640 ELI WHITNEY DR
| COLUMBIA |
MD |
21046 |
K112409 |
ACELL, INC |
6640 ELI WHITNEY DRIVE
| COLUMBIA |
MD |
21046 |
K153754 |
ACELL, INC |
6640 ELI WHITNEY DRIVE
| COLUMBIA |
MD |
21046 |
K192725 |
ACell, Inc. |
6640 Eli Whitney Drive Suite 200
| Columbia |
MD |
21046 |
K180776 |
ACell, Inc. |
6640 Eli Whitney Drive Suite 200
| Columbia |
MD |
21046 |
K172399 |
ACell, Inc. |
6640 Eli Whitney Drive, Suite 200
| Columbia |
MD |
21046 |
K230980 |
ACell, Inc. |
6640 Eli Whitney Drive Suite 200
| Columbia |
MD |
21046 |
K162348 |
ACRO BIOMEDICAL CO., LTD |
3F., NO.57, LUKE 2ND RD, LUJHU DIST.
| Kaohsiung City |
|
82151 |
K000054 |
ADRI |
P.O. BOX 134
| PARK FOREST |
IL |
60466 |
K003134 |
ADRI/TECHNAM |
P.O. BOX 134
| PARK FOREST |
IL |
60466 |
K080868 |
AEON ASTRON EUROPE B.V. |
NIELS BOHRWEG 11-13
| LEIDEN |
|
2333 |
K173223 |
Aeon Astron Europe B.V. |
J.H. Oortweg 19
| Leiden |
|
2333 CH |
K081724 |
APPLIED NUTRITIONALS |
1890 BUCKNELL DR.
| BETHLEHEM |
PA |
18015 |
K171231 |
Aroa Biosurgery |
2 Kingsford Smith Place
| Airport Oaks |
|
2022 |
K200502 |
Aroa Biosurgery Ltd. |
2 Kingsford Smith Place
| Airport Oaks |
|
2022 |
K200413 |
Aroa Biosurgery Ltd. |
2 Kingsford Smith Place
| Airport Oaks |
|
2022 |
K082869 |
AUBREY, INC. |
5930 SEA LION PLACE
| CARLSBAD |
CA |
92010 |
K012990 |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
11800 TECH ROAD,
| SILVER SPRING |
MD |
20904-1908 |
K134037 |
BIOTIME, INC. |
8708 CAPEHART COVE
| AUSTIN |
TX |
78733 |
K113866 |
BRENNEN MEDICAL, LLC |
1290 HAMMOND RD.
| ST. PAUL |
MN |
55110 |
K182010 |
Cell Constructs I, LLC |
7828 Hickory Flat Highway Suite 120
| Woodstock |
GA |
30188 |
K120250 |
COLLAFIRM LLC |
7 DEER PARK DRIVE
| MONMOUTH JUNCTION |
NJ |
08852 |
K122115 |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD
| OAKLAND |
NJ |
07436 |
K152600 |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD
| OAKLAND |
NJ |
07436 |
K030921 |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST.
| FRANKLIN LAKES, |
NJ |
07417 |
K040403 |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST.
| FRANKLIN LAKES, |
NJ |
07417 |
K213341 |
Collagen Matrix, Inc. |
15 Thornton Road
| Oakland |
NJ |
07436 |
K040211 |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST.
| FRANKLIN LAKES, |
NJ |
07417 |
K040558 |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST.
| FRANKLIN LAKES, |
NJ |
07417 |
K061474 |
COLLAMATRIX CO., INC. |
2ND FLOOR, NO. 360, RUIGUANG
| TAIPEI |
|
114 |
K070269 |
COLLAMATRIX CO., INC. |
NO. 360 RUIGUANG ROAD, 2ND FL.
| TAIPEI |
|
114 |
K984388 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K990964 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
100 HEADQUARTERS PARK DR.
| SKILLMAN |
NJ |
08558 |
K152033 |
Cook Biotech Incorporated |
1425 Innovation Place
| West Lafayette |
IN |
47906 |
K160136 |
COOK BIOTECH INCORPORATED |
1425 INNOVATION PLACE
| WEST LAFAYETTE |
IN |
47906 |
K061711 |
COOK BIOTECH, INC. |
1425 INNOVATION PLACE
| WEST LAFAYETTE |
IN |
47906-1000 |
K973170 |
COOK BIOTECH, INC. |
P.O. BOX 2603, 3055 KENT AVE.
| WEST LAFAYETTE |
IN |
47906 |
K993948 |
COOK BIOTECH, INC. |
3055 KENT AVE.
| WEST LAFAYETTE |
IN |
47906-1076 |
K020732 |
COOK BIOTECH, INC. |
3055 KENT AVE.
| WEST LAFAYETTE |
IN |
47906-1076 |
K102946 |
CORELEADER BIOTECH CO., LTD. |
19F NO. 100, SEC 1
| TAIPEI, TAIWAN |
|
22102 |
K123756 |
COVALON TECHNOLOGIES LTD. |
405 BRITANNIA ROAD EAST
| MISSISSAUGA, ONTARIO |
|
L4Z 3E6 |
K050177 |
COVALON TECHNOLOGIES, INC. |
14510 KANDI COURT
| LARGO |
FL |
33774 |
K112580 |
DALIM TISSEN CO., LTD. |
325 N PUENTE STREET
| BREA |
CA |
92821 |
K040314 |
ENCOLL CORP. |
5686 GERANIUM CT.
| NEWARK |
CA |
94560 |
K192346 |
Freudenberg Technology Innovation SE & Co. KG |
Hoehnerweg 2-4
| Weinheim |
|
69469 |
K182838 |
Geistlich Pharma AG |
Bahnhofstrasse 40
| Wolhusen |
|
CH-6110 |
K171842 |
Geistlich Pharma AG |
Bahnhofstrasse 40
| Wolhusen |
|
CH-6110 |
K213607 |
Geistlich Pharma AG |
Bahnhofstrasse 40
| Wolhusen |
|
6110 |
K191992 |
Gunze Limited |
46 Natsumegaichi, Aono
| Ayabe, Kyoto |
|
623-8513 |
K213498 |
Gunze Limited |
46 Natsumegaichi, Aono
| Ayabe, Kyoto |
|
623-8513 |
K213573 |
Gunze Limited |
46 Natsumegaichi, Aono
| Ayabe, Kyoto |
|
623-8513 |
K140367 |
HARBOR MEDTECH, INC. |
4 JENNER
| IRVINE |
CA |
92618 |
K122502 |
HARBOR MEDTECH, INC. |
4 JENNER
| IRVINE |
CA |
92618 |
K091338 |
HARTMANN-CONCO INC. |
1468 HARWELL AVE.
| CROFTON |
MD |
21114 |
K213598 |
Huizhou Foryou Medical Devices CO., Ltd. |
No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park
| Huizhou |
|
516000 |
K213092 |
Human Biosciences, Inc. |
940 Clopper Rd.
| Gaithersburg |
MD |
20878 |
K122325 |
HUMAN BIOSCIENCES, INC. |
2913, 209TH LANE NW
| OAK GROVE |
MN |
55011 |
K133290 |
INNOCOLL PHARMACEUTICALS |
DUBLIN ROAD
| ATHLONE, CO. WESTMEATH |
|
|
K092805 |
INNOCOLL PHARMACEUTICALS |
DUBLIN ROAD
| ATHLONE, CO. WESTMEATH |
|
|
K061746 |
INNOCOLL PHARMACEUTICALS |
IDA BUSINESS AND TECHNOLOGY
| ATHLONE, CO. WESTMEATH |
|
|
K100574 |
INNOCOLL PHARMACEUTICALS |
DUBLIN ROAD
| ATHLONE, CO. WESTMEATH |
|
|
K081782 |
INNOCOLL PHARMACEUTICALS |
DUBLIN ROAD
| ATHLONE, CO. WESTMEATH |
|
|
K120339 |
INNOCOLL PHARMACEUTICALS |
DUBLIN ROAD
| ATHLONE, CO. WESTMEATH |
|
|
K110388 |
INNOCOLL PHARMACEUTICALS LTD |
MIDLANDS RESEARCH AND
| ATHLONE, CO. WESTMEATH |
|
EI |
K103648 |
INNOCOLL PHARMACEUTICALS LTD |
MIDLANDS RESEARCH AND
| ATHLONE, CO. WESTMEATH |
|
EI |
K022127 |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K021792 |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K072113 |
INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE
| PLAINSBORO |
NJ |
08536 |
K081635 |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K210128 |
Integra LifeSciences Corporation |
1100 Campus Road
| Princeton |
NJ |
08540 |
K113104 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K982597 |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD.
| ARLINGTON |
TX |
76004-0130 |
K970266 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST.
| MANSFIELD |
MA |
02048 |
K112888 |
KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE
| EXTON |
PA |
19341 |
K141738 |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
735 PENNSYLVANIA DRIVE
| EXTON |
PA |
19341 |
K192386 |
KeraNetics |
200 East First Street, Suite 101, Box#4
| Winston Salem |
NC |
27101 |
K162759 |
KeraNetics, LLC. |
200 East First Stree, Box #4, Suite 102
| Winston-Salem |
NC |
27101 |
K213231 |
Kerecis Limited |
Eyrargata 2
| Isafjordur |
|
400 |
K132343 |
KERECIS LIMITED |
EYRARGATA 2
| ISAFIJORDUR |
|
400 |
K190528 |
Kerecis Limited |
Eyrargata 2
| Isafjordur |
|
400 |
K082103 |
LIFECELL CORP. |
ONE MILLENNIUM WAY
| BRANCHBURG |
NJ |
08876 |
K100927 |
MAXIGEN BIOTECH, INC. |
2904 N BOLDT AVE
| FLAGSTAFF |
AZ |
86001 |
K060456 |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE
| MUNDELEIN |
IL |
60060 |
K201577 |
MedSkin Solutions Dr. Suwelack AG |
Josef-Suwelack-Strasse 2
| Billerbeck |
|
48727 |
K000487 |
MEDTRADE PRODUCTS LTD. |
ELECTRA HOUSE
| CREWE, CHESHIRE |
|
CW1 6GL |
K101546 |
MESYNTHES LTD |
49 PLAIN STREET
| NORTH ATTLEBORO |
MA |
02760-2237 |
K092096 |
MESYNTHES LTD |
49 PLAIN STREET
| NORTH ATTLEBORO |
MA |
02760-4153 |
K140510 |
MIROMATRIX MEDICAL INC. |
400 N. WASHINGTON ST., STE 100
| ALEXANDRIA |
VA |
22314 |
K143426 |
MIROMATRIX MEDICAL INC. |
18683 Bearpath Trail
| Eden Prairie |
MN |
55347 |
K140456 |
MLM BIOLOGICS, INC. |
12085 RESEARCH DRIVE
| ALACHUA |
FL |
32615 |
K210024 |
NeXtGen Biologics, Inc. |
13709 Progress Blvd Box11
| Alachua |
FL |
32615 |
K181330 |
NeXtGen Biologics, Inc. |
747 SW 2nd Ave - IMB 5
| Gainesville |
FL |
32601 |
K142712 |
NovaBone Products, LLC |
13510 NW US Highway 441
| Alachua |
FL |
32615 |
K220498 |
Novabone Products, LLC |
13510 NW US Highway 441
| Alachua |
FL |
32615 |
K002443 |
OASIS RESEARCH, LLC. |
514 S. VERMONT AVE.
| GLENDORA |
CA |
91741 |
K212579 |
Organogenesis Inc. |
150 Dan Rd
| Canton |
MA |
02021 |
K220317 |
Organogenesis Inc. |
150 Dan Road
| Canton |
MA |
02021 |
K011026 |
ORGANOGENESIS, INC. |
150 DAN RD.
| CANTON |
MA |
02021 |
K061494 |
PEGASUS BIOLOGICS, INC. |
6 JENNER
| IRVINE |
CA |
92618 |
K071425 |
PEGASUS BIOLOGICS, INC. |
6 JENNER
| IRVINE |
CA |
92618 |
K223257 |
Reprise Biomedical |
17400 Medina Road
| Plymouth |
MN |
55447 |
K221520 |
Reprise Biomedical, Inc. |
17400 Medina Road Suite 100
| Plymouth |
MN |
55447 |
K090812 |
SEWON CELLONTECH CO., LTD. |
13340 E. FIRESTONE BLVD.
| SANTA FE SPRINGS |
CA |
90670 |
K030774 |
SOUTHWEST TECHNOLOGIES, INC. |
1746 LEVEE RD.
| KANSAS CITY |
MO |
64116 |
K172593 |
StemSys |
10871 NW 52nd St, Ste 4
| Sunrise |
FL |
33351 |
K171645 |
Strukmyer Medical |
1801 Big Town Blvd Suite #100
| Mesquite |
TX |
75149 |
K112399 |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
6 Jenner, Suite 150
| IRVINE |
CA |
92618 |
K023778 |
TEI BIOSCIENCES INC. |
7 ELKINS ST.
| BOSTON |
MA |
02127 |
K061407 |
TEI BIOSCIENCES INC. |
7 ELKINS ST.
| BOSTON |
MA |
02127 |
K083440 |
TEI BIOSCIENCES INC. |
7 ELKINS ST.
| BOSTON |
MA |
02127 |
K131286 |
TEI BIOSCIENCES INC. |
7 ELKINS ST.
| BOSTON |
MA |
02127 |
K153690 |
TEI BioSciences Inc. |
7 Elkins Street
| Boston |
MD |
02127 |
K955506 |
THE HYMED GROUP CORP. |
1890 BUCKNELL DR.
| BETHLEHEM |
PA |
18015 |
K994339 |
THE HYMED GROUP CORP. |
1890 BUCKNELL DR.
| BETHLEHEM |
PA |
18015 |
K110318 |
TISSUE REPAIR COMPANY |
12255 EL CAMINO REAL
| SAN DIEGO |
CA |
92130 |
K213716 |
Triad Life Sciences, Inc. |
1770 Moriah Woods Blvd, Suite 18
| Memphis |
TN |
38117 |
K193552 |
Triad Life Sciences, Inc. |
1770 Moriah Woods Blvd, Suite 18
| Memphis |
TN |
38117 |
K210580 |
Triad Life Sciences, Inc. |
1770 Moriah Woods Blvd, Suite 18
| Memphis |
TN |
38117 |
K211902 |
Triad Life Sciences, Inc. |
1770 Moriah Woods Blvd, Suite 18
| Memphis |
TN |
38117 |
K140820 |
VISCUS BIOLOGICS LLC |
P.O.BOX 560
| STILLWATER |
MN |
55082 |
K090954 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
|
|