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 |
| K241724 | 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 |
| K241706 | ACell, Inc |
6640 Eli Whitney Dr. | 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 | |
| K233378 | 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 |
| K243071 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| 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 | |
| K241866 | Convatec Triad Life Sciences, LLC |
1770 Moriah Woods Blvd. | Memphis | TN | 38117 |
| 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 |
| K241904 | FesariusTherapeutics Inc. |
760 Parkside Avenue, Suite 218 | Brooklyn | NY | 11226 |
| K232204 | FetTech |
10871 NW 52nd St | Sunrise | FL | 33351 |
| 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 | |
| K250329 | GeniPhys, Inc. |
7750 Zionsville Road, Suite 200 | Indianapolis | IN | 46268 |
| 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 | |
| K232796 | 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 |
| K241080 | Kerecis Limited |
Sundstraeti 38, 400 Isafjordur | Isafjordur | ||
| K213231 | Kerecis Limited |
Eyrargata 2 | Isafjordur | 400 | |
| K132343 | KERECIS LIMITED |
EYRARGATA 2 | ISAFIJORDUR | 400 | |
| K190528 | Kerecis Limited |
Eyrargata 2 | Isafjordur | 400 | |
| K251845 | Kerecis Limited |
Sundastraeti 38, 400 Isafjordur | Isafjordur | 400 | |
| K082103 | LIFECELL CORP. |
ONE MILLENNIUM WAY | BRANCHBURG | NJ | 08876 |
| K100927 | MAXIGEN BIOTECH, INC. |
2904 N BOLDT AVE | FLAGSTAFF | AZ | 86001 |
| K223126 | Maxigen Biotech, Inc. |
No. 88, Keji 1st Rd., Guishan District | Taoyuan City | 333411 | |
| 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 |
| K963228 | ORPHAN MEDICAL, INC. |
13911 RIDGEDALE DR., SUITE 475 | MINNETONKA | MN | 55305 |
| K242985 | OviGenex LLC |
2630 Homestead Place | Rancho Dominguez | CA | 90220 |
| 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 |
| K240753 | Reprise Biomedical, Inc. |
17400 Medina Road | Plymouth | MN | 55447 |
| K221520 | Reprise Biomedical, Inc. |
17400 Medina Road Suite 100 | Plymouth | MN | 55447 |
| K240277 | Reprise Biomedical, Inc. |
17400 Medina Road | Plymouth | MN | 55447 |
| K231614 | 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 |
| K242146 | Smith & Nephew Medical Limited |
101 Hessle Road | Hull | HU3 2BN | |
| K030774 | SOUTHWEST TECHNOLOGIES, INC. |
1746 LEVEE RD. | KANSAS CITY | MO | 64116 |
| K172593 | StemSys |
10871 NW 52nd St, Ste 4 | Sunrise | FL | 33351 |
| K231325 | StimLabs, LLC |
1225 Northmeadow Parkway, Suite 104 | Roswell | GA | 30076 |
| K242828 | StimLabs, LLC |
1225 Northmeadow Parkway | Roswell | GA | 30011 |
| K171645 | Strukmyer Medical |
1801 Big Town Blvd Suite #100 | Mesquite | TX | 75149 |
| K232758 | Strukmyer Medical, LLC. |
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 |
| K231152 | Winner Medical Co., Ltd. |
Winner Industrial Park, No. 660 Bulong Road, | Shenzhen | 518109 | |
| K090954 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
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