FDA 510(k) Applications for Medical Device:
Mesh, Surgical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040621 | ACELL, INC |
5610 WISCONSIN AVE | CHEVY CHASE | MD | 20815 |
| K041140 | ACELL, INC |
5610 WISCONSIN AVE | CHEVY CHASE | MD | 20815 |
| K141084 | ACELL, INC |
6640 ELI WHITNEY DR | COLUMBIA | MD | 21046 |
| K162554 | Acell, Inc. |
6640 Eli Whitney Drive | Columbia | MD | 21046 |
| K170763 | ACell, Inc. |
6640 Eli Whitney Drive | Columbia | MD | 21046 |
| K182259 | ACell, Inc. |
6640 Eli Whitney Drive Suite 200 | Columbia | MD | 21046 |
| K203600 | Alafair Biosciences Inc |
6101 W Courtyard Drive ste 2-225 | Austin | TX | 78730 |
| K213163 | Alafair Biosciences Inc |
6101 W Courtyard Drive Suite 2-225 | Austin | TX | 78730 |
| K200311 | Alafair Biosciences Inc |
6101 W Courtyard Drive ste 2-225 | Austin | TX | 78730 |
| K073219 | AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST | MINNETONKA | MN | 55343 |
| K162461 | AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) |
2 KINGSFORD SMITH PLACE, AIRPORT OAKS | AUCKLAND | 2022 | |
| K153633 | Aroa Biosurgery Limited (Formerly Mesynthes Limited) |
2 Kingsford Smith Place, Airport Oaks | Auckland | 2022 | |
| K250598 | Aroa Biosurgery Ltd. |
2 Kingsford Smith Place | Auckland | 2022 | |
| K183398 | Aroa Biosurgery Ltd. |
2 Kingsford Smith Place | Airport Oaks | 2022 | |
| K173242 | Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 | Roswell | GA | 30076 |
| K201313 | Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 | Roswell | GA | 30076 |
| K192616 | Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 | Roswell | GA | 30076 |
| K182255 | Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 | Roswell | GA | 30076 |
| K192452 | B. Bruan Surgical, SA |
Carretera Terrassa 121 | Rubi | 08191 | |
| K961811 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K983162 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K971048 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K992537 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K961810 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K062558 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K111436 | BRENNEN MEDICAL, LLC |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K081272 | BRENNEN MEDICAL, LLC |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K140501 | C.R. BARD |
100 CROSSINGS BOULEVARD | WARWICK | RI | 02886 |
| K052322 | C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K063178 | C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K031332 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K082687 | C.R. BARD, INC. |
100 CROSSINGS BOULEVARD | WARWICK | RI | 02886 |
| K021160 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K141721 | COLLAFIRM LLC |
7 Deer Park Drive | Monmouth Jct | NJ | 08852 |
| K080452 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES | NJ | 07417 |
| K160181 | Colorado Therapeutics LLC |
2150 WEST 6TH AVENUE | BROOMFIELD | CO | 80020 |
| K172937 | Colorado Therapeutics LLC |
2150 West 6th Avenue, Suite L | Bloomfield | CA | 80020 |
| K171817 | Cook Biotech Incorporated |
1425 Innovation Place | West Lafayette | IN | 47906 |
| K170016 | Cook Biotech Incorporated |
1425 Innovation Place | West Lafayette | IN | 47906 |
| K162934 | Cook Biotech Incorporated |
1425 Innovation Place | West Lafayette | IN | 47906 |
| K161221 | Cook Biotech Incorporated |
1425 Innovation Place | West Lafayette | IN | 47906 |
| K201000 | Cook Biotech Incorporated |
1425 Innovation Place | West Lafayette | IN | 47906 |
| K160869 | COOK BIOTECH INCORPORATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906 |
| K150668 | COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906 |
| K142887 | COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K110402 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K070405 | COOK BIOTECH, INC. |
1400 CUMBERLAND AVE. | WEST LAFAYETTE | IN | 47906 |
| K050246 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K070738 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K050337 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K133306 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906 |
| K034039 | COOK BIOTECH, INC. |
3055 KENT AVE. | WEST LAFAYETTE | IN | 47906-1076 |
| K980431 | COOK BIOTECH, INC. |
P.O. BOX 2603, 3055 KENT AVE. | WEST LAFAYETTE | IN | 47906 |
| K082682 | COOK BIOTECH, INC. |
1 Geddes Way | West Lafayette | IN | 47906 |
| K073391 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K062320 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K062729 | COOK BIOTECH, INC. |
1400 CUMBERLAND AVE. | WEST LAFAYETTE | IN | 47906 |
| K051048 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K062696 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K140306 | CORMATRIX CARDIOVASCULAR, INC. |
1100 OLD ELLIS ROAD | ROSWELL | GA | 30076 |
| K120605 | Covidien LLC |
15 CROSBY DR | BEDFORD | MA | 01730 |
| K061892 | CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. | KENNESAW | GA | 30144 |
| K101587 | CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. | KENNESAW | GA | 30144 |
| K110581 | CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. | KENNESAW | GA | 30144 |
| K162388 | CURASEAL, INC. |
2231 CALLE DE LUNA | SANTA CLARA | CA | 95054 |
| K031969 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K071016 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K001738 | DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 | WARSAW | IN | 46581-0988 |
| K982330 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K233991 | Elutia Inc. |
1100 Old Ellis Road | Roswell | GA | 30076 |
| K203496 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 6110 | |
| K040868 | GENZYME CORP. |
500 KENDALL STREET | CAMBRIDGE | MA | 02142 |
| K963175 | GLYCAR, INC. |
4537 BELCLAIRE AVE. | DALLAS | TX | 75205 |
| K040756 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K053655 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K041923 | KENSEY NASH CORP. |
55 EAST UWCHLAN AVE. | EXTON | PA | 19341 |
| K043259 | KENSEY NASH CORP. |
55 EAST UWCHLAN AVE. | EXTON | PA | 19341 |
| K103787 | KENSEY NASH CORP. |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K091499 | KENSEY NASH CORP. |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K061030 | KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K094061 | KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K132025 | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K070560 | LIFECELL CORP. |
ONE MILLENNIUM WAY | BRANCHBURG | NJ | 08876 |
| K082176 | LIFECELL CORP. |
ONE MILLENNIUM WAY | BRANCHBURG | NJ | 08876 |
| K071986 | LIFECELL CORP. |
ONE MILLENNIUM WAY | BRANCHBURG | NJ | 08876 |
| K162752 | LIFECELL CORPORATION |
ONE MILLENNIUM WAY | BRANCHBURG | NJ | 08876 |
| K142326 | LifeCell Corporation |
One Millennium Way | Branchburg | NJ | 08876 |
| K150712 | LifeCell Corporation |
One Millennium Way | Branchburg | NJ | 08876 |
| K130547 | MESYNTHE LTD |
11440 W. BERNARDO CT | SAN DIEGO | CA | 92127 |
| K134033 | MIROMATRIX MEDICAL INC. |
400 N. WASHINGTON ST., STE 100 | ALEXANDRIA | VA | 22314 |
| K162570 | Miromatrix Medical Inc. |
18683 Bearpath Trail | Eden Prairie | MN | 55344 |
| K042809 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K011025 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K020049 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K021105 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K011027 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K021107 | ORGANOGENESIS, INC. |
150 DAN RD. | CANTON | MA | 02021 |
| K071065 | PEGASUS BIOLOGICS, INC. |
6 JENNER | IRVINE | CA | 92618 |
| K043388 | PEGASUS BIOLOGICS, INC. |
10 PASTEUR ST. | IRVINE | CA | 92618 |
| K063556 | PM DEVICES, INC. |
13700 MAYFIELD PL. | RICHMOND | V6V 2E4 | |
| K040835 | PM DEVICES, INC. |
2135-13700 MAYFIELD PLACE | RICHMOND, BC | V6V 2E4 | |
| K033985 | PM DEVICES, INC. |
2135-13700 MAYFIELD PLACE | RICHMOND, BC | V6V 2E4 | |
| K040364 | POREX SURGICAL, INC. |
15 DART RD. | NEWNAN | GA | 30265 |
| K112423 | ROTATION MEDICAL, INC. |
15350 25TH AVENUE N | PLYMOUTH | MN | 55447 |
| K122048 | ROTATION MEDICAL, INC. |
15350 25TH AVENUE N | PLYMOUTH | MN | 55447 |
| K123356 | RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE | ALACHUA | FL | 32616-1627 |
| K081538 | RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE | ALACHUA | FL | 32616-1627 |
| K091142 | RTI BIOLOGICS, INC. |
11621 RESEARCH CIRCLE | ALACHUA | FL | 32616-1627 |
| K142070 | RTI SURGICAL, INC. |
11621 Research Cir | ALACHUA | FL | 32615 |
| K973379 | S. JACKSON, INC. |
15 ROTH ST. | ALEXANDRIA | VA | 22303 |
| K991567 | SHELHIGH, INC. |
67 E. WILLOW ST. | MILLBURN | NJ | 07041 |
| K223052 | Synovis Life Technologies, Inc. |
A Subsidiary of Baxter International Inc.) | St. Paul | MN | 55114 |
| K192615 | Synovis Life Technologies, Inc. (Baxter International Inc.) |
2575 University Ave. W | St. Paul | MN | 55114 |
| K213125 | Synovis Life Technologies. Inc. (A Subsidiary Of Baxter |
International Inc.) | St. Paul | MN | 55114 |
| K113460 | SYNOVIS ORTHOPEDIC & WOUNDCARE |
6 Jenner, Suite 150 | IRVINE | CA | 92618 |
| K112786 | SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. |
6 JENNER | IRVINE | CA | 92618 |
| K040119 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K062915 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K083039 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. WEST | ST. PAUL | MN | 55114-1024 |
| K041669 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. WEST | ST. PAUL | MN | 55114-1024 |
| K051879 | SYNTHES (USA) |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K183472 | Synthes (USA) Products LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K060829 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K071807 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K083898 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K162965 | TEI Biosciences Inc. |
7 Elkins Street | Boston | MA | 02127 |
| K020455 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K060989 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K060984 | TEI BIOSCIENCES INC. |
7 ELKINS ST. | BOSTON | MA | 02127 |
| K214070 | TELA Bio |
1 Great Valley Parkway, Suite 24 | Malvern | PA | 19355 |
| K141053 | TELA BIO, INC. |
1 GREAT VALLEY PARKWAY, SUITE 24 | MALVEN | PA | 19355 |
| K241126 | Tela Bio, Inc. |
1 Great Valley Parkway | Malvern | PA | 19355 |
| K243595 | TELA Bio, Inc. |
1 Great Valley Parkway | Malvern | PA | 19355 |
| K182493 | Tisgenx |
15615 Alton Parkway, Suite 450 | Irvine | CA | 92618 |
| K152206 | TISSUE REGENIX GROUP PLC |
THE BIOCENTRE, INNOVATION WAY, HESLINGTON | YORK | YO20 5NY | |
| K013625 | TISSUE SCIENCE LABORATORIES, PLC |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K021056 | TISSUE SCIENCE LABORATORIES, PLC |
555 THIRTEENTH ST. N.W. | WASHINGTON | DC | 20004-1109 |
| K053562 | TISSUE SCIENCE LABORATORIES, PLC |
1141 CLARK STREET, SUITE D | COVINGTON | GA | 30014 |
| K991296 | TUTOGEN MEDICAL U.S., INC. |
13709 PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K030782 | W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. | FLAGSTAFF | AZ | 86001 |
| K120019 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K081882 | XYLOS CORPORATION |
838 TOWN CENTER DR. | LANGHORNE | PA | 19047 |
| K090778 | XYLOS CORPORATION |
838 TOWN CENTER DR. | LANGHORNE | PA | 19047 |
| K083823 | XYLOS CORPORATION |
838 TOWN CENTER DR. | LANGHORNE | PA | 19047 |
| K111584 | XYLOS CORPORATION |
838 TOWN CENTER DR. | LANGHORNE | PA | 19047 |
| K090880 | XYLOS CORPORATION |
838 TOWN CENTER DR. | LANGHORNE | PA | 19047 |
| K023237 | XYLOS CORPORATION |
815 CONNECTICUT AVE., NW. | WASHINGTON | DC | 20006 |
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