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 |
|
|