FDA 510(k) Applications for Medical Device:
Barrier, Animal Source, Intraoral

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K103087 BIOM'UP SAS 8, ALLEE IRENE JOLIOT-CURIE
ST-PRIEST 69800
K053260 COLBAR LIFESCIENCE LTD. 555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
K110600 COLLAGEN MATRIX, INC. 15 THORNTON ROAD
OAKLAND NJ 07436
K011695 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417
K142496 COLLAGEN MATRIX, INC. 15 THORNTON ROAD
OAKLAND NJ 07436
K141909 COLLAGEN MATRIX, INC. 15 THORNTON ROAD
OAKLAND NJ 07436
K062846 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417
K090216 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES NJ 07417
K100156 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES NJ 07417
K062881 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417
K003339 COLLAGEN MATRIX, INC. 509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417
K100695 COLLAMATRIX, INC 26F, NO. 105, SECTION 2 DUNHUA
TAIPEI 106
K161762 COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE
West Lafayette IN 47906
K082058 COOK BIOTECH, INC. 11234 EL CAMINO REAL
SAN DIEGO CA 92130
K010952 COOK BIOTECH, INC. 3055 KENT AVE.
WEST LAFAYETTE IN 47906-1076
K212509 Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170
Lod 7116003
K160281 Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170
Lod 7116003
K153549 Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170
Lod 7116003
K050446 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE 1301 K STREET NW
WASHINGTON DC 20005
K042197 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE 1301 K STREET NW
WASHINGTON DC 20005
K012423 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE 1050 CONNECTICUT AVE. NW
WASHINGTON DC 20036
K061244 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE 1300 I STREET, N.W.
WASHINGTON DC 20005
K073711 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE 1300 I STREET, N.W.
WASHINGTON DC 20005
K102531 ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE 1300 I STREET, N.W., 11TH FL
WASHINGTON DC 20005
K171643 Geistlich Pharma AG Bahnhofstrasse 40
Wolhusen ch- 6110
K212463 Geistlich Pharma AG Bahnhofstrasse 40
Wolhusen CH-6110
K192042 Geistlich Pharma AG Bahnhofstrasse 40
Wolhusen CH-6110
K171050 Geistlich Pharma AG Bahnhofstrasse 40
Wolhusen 6110
K140518 GEISTLICH PHARMA AG 555 twelfth Street, NW
Washington DC 20004
K210280 Geistlich Pharma AG Bahnhofstrasse 40
Wolhusen CH-6110
K102307 GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A
CYPRESS CA 90630
K173562 Institut Straumann AG Peter Merian Weg 12
Basel CH-4002
K090919 KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE
EXTON PA 19341
K091192 KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE
EXTON PA 19341
K121310 KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE
EXTON PA 19341
K160474 Kensey Nash Corporation dba DSM Biomedical 735 Pennsylvania Drive
Exton PA 19431
K213904 Kerecis Eyrargata 2
Isafjordur 400
K192612 Kerecis Limited Eyrargata 2
Isafjordur 400
K123697 MATRICEL GMBH KAISERSTRABE 100
HERZOGENRATH 52134
K133507 NIBEC CO LTD 4568 W. 1ST STREET, STE 104
LOS ANGELES CA 90004
K101453 OBI BIOLOGICS, INC. 4620 71ST STREET, BLDG 79
LUBBOCK TX 79424
K071555 ORGANOGENESIS, INC. 150 DAN RD.
CANTON MA 02021
K201241 Orthocell Ltd Building 191 Murdoch University, South St, MURDOCH
Perth 6150
K073685 OSSEOUS TECHNOLOGIES OF AMERICA 11234 EL CAMINO REAL
SAN DIEGO CA 92130
K141177 OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI 4620 71ST ST, BLDG 78
LUBBOCK TX 79424
K230091 Purgo Biologics Inc. #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu
Seongnam-si 13219
K223912 SigmaGraft Inc. 575 Sally Place
Fullerton CA 92831
K200623 Sk bioland Co., Ltd. 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu
Cheongju-si 28125
K073097 TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD.
ALACHUA FL 32615




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