FDA 510(k) Applications for Medical Device:
Barrier, Animal Source, Intraoral
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K231305 | Aroa Biosurgery Ltd. |
2 Kingsford Smith Place | Auckland | 2022 | |
| K231513 | Beijing Biosis Healing Biological Technology Co., Ltd. |
No.6 Plant West, Valley No.1 Bio-medicine Industry Park | Beijing | 102600 | |
| 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 |
| K233203 | Collagen Matrix, Inc. |
15 Thornton Rd. | Oakland | NJ | 07436 |
| 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 | |
| K250833 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 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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