FDA 510(k) Applications for Medical Device:
Suture, Nonabsorbable, Synthetic, Polyethylene
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952535 | ACUFEX MICROSURGICAL, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K012201 | AESCULAP, INC. |
13221 MARICOTTE PLACE | SAN DIEGO | CA | 92130 |
| K990088 | AESCULAP, INC. |
ONE AMERICA PLAZA, SUITE 900 | SAN DIEGO | CA | 92101-3302 |
| K213046 | AlloSource |
6278 S. Troy Circle | Centennial | CO | 80111 |
| K170957 | AlloSource |
6278 S Troy Circle | Centennial | CO | 80111 |
| K133770 | ANCHOR INNOVATION MEDICAL (A.I.M.) |
5410 EDSON LANE, SUITE 308 | ROCKVILLE | MD | 20852 |
| K061386 | ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 | MINNETONKA | MN | 55343 |
| K100572 | ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 | MINNETONKA | MN | 55343 |
| K062307 | ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 | MINNETONKA | MN | 55343 |
| K091432 | ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 | MINNETONKA | MN | 55343 |
| K000540 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. | SYOSSET | NY | 11791 |
| K180191 | Arcuro Medical Ltd. |
17 Tchelet St. | Misgav | 2017400 | |
| K223500 | Arcuro Medical Ltd. |
17 Tchelet St. | Misgav | 2017400 | |
| K121306 | ARTHOCARE CORPORATION |
7000 WEST WILLIAM CANNON DRIVE | AUSTIN | TX | 78735 |
| K123268 | ARTHOCARE CORPORATION |
7000 West William Cannon Drive | Austin | TX | 78735 |
| K220880 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K190707 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K193575 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K221354 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K222078 | Arthrex, Inc |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K112899 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K140019 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K032245 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K071622 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K021434 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K041589 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K010673 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K012923 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K212146 | Arthrex, Inc. |
1370 Creekside Boulevard | Naples | FL | 34108 |
| K132043 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K122374 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K041553 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K073149 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K171296 | Arthrex, Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K163142 | ArthroCare Corporation |
15285 Alton Parkway | Irvine | CA | 92618 |
| K033718 | ARTHROTEK, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K070253 | AXYA MEDICAL, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K060165 | AXYA MEDICAL, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K063194 | AXYA MEDICAL, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K151009 | BAYLIS MEDICAL COMPANY INC. |
2645 MATHESON BLVD. EAST | MISSISSAUGA | L4W 5S4 | |
| K092533 | BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF |
5307 95TH AVE. | KENOSHA | WI | 53144 |
| K160854 | Biomet Manafacturing Corp. |
56 East Bell Drive | Warsaw | IN | 46581 |
| K163651 | Biomet Manufacturing Corp. |
56 East Bell Drive | Warsaw | IN | 46581 |
| K152868 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE PO BOX 587 | WARSAW | IL | 46581 |
| K071796 | CAYENNE MEDICAL, INC. |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K121413 | CAYENNE MEDICAL, INC. |
16597 N. 92ND STREET | SCOTTSDALE | AZ | 85260 |
| K082518 | CAYENNE MEDICAL, INC. |
16597 N. 92ND STREET | SCOTTSDALE | AZ | 85260 |
| K143356 | Ceterix Orthopaedics, Inc. |
959 Hamilton Ave | Menlo Park | CA | 94025 |
| K180531 | Ceterix Orthopaedics, Inc. |
6500 Kaiser Drive, Suite 120 | Fremont | CA | 94555 |
| K181772 | Ceterix Orthopaedics, Inc. |
6500 Kaiser Drive, Suite 120 | Fremont | CA | 94555 |
| K220186 | CONMED Corporation |
525 French Road | Utica | NY | 13502 |
| K102339 | CONMED LINVATEC |
11311 CONCEPT BOULEVARD | LARGO | FL | 33773-4908 |
| K090128 | CORE ESSENCE ORTHOPAEDICS, INC. |
301 OXFORD VALLEY RD. | YARDLEY | PA | 19067 |
| K103052 | Covidien LLC |
60 MIDDLETOWN AVENUE | NORTH HAVEN | CT | 06473 |
| K094028 | CP MEDICAL |
803 NE 25TH AVE. | PORTLAND | OR | 97232 |
| K041894 | CP MEDICAL |
803 N.E. 25TH AVENUE | PORTLAND | OR | 97232 |
| K001172 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K230510 | Cynosure, LLC |
5 Carlisle Road | Westford | MA | 01886 |
| K023030 | DEMETECH CORP. |
12119 SW 131 AVE. | MIAMI | FL | 33186 |
| K190777 | DemeTECH Corporation |
14175 NW 60th Ave | Miami Lakes | FL | 33014 |
| K150327 | Dunamis LLC |
693 Sherling Lake Rd. | Greenville | AL | 36037 |
| K153746 | Dunamis LLC |
693 Sherling Lake Rd. Apt. 122 | Greenville | AL | 36037 |
| K013990 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K223822 | Embody, Inc. |
4211 Monarch Way, Suite 500 | Norfolk | VA | 23508 |
| K073096 | EPITEK, INC. |
4801 W. 81ST STREET | BLOOMINGTON | MN | 55437 |
| K060367 | FOURNITURES HOSPITALIERES INDUSTRIE |
ZI DE KERNEVEZ-6 RUE NOBEL | QUIMPER | 29000 | |
| K022410 | GENZYME BIOSURGERY |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K021019 | GENZYME CORP. |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K001434 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K001440 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K003590 | GRAMSMED LLC |
2225 DAKOTA DR. | GRAFTON | WI | 53024 |
| K091061 | IMPLICITCARE, LLC |
13221 MARICOTTE PLACE | SAN DIEGO | CA | 92130 |
| K153087 | Ivy Sports Medicine, LLC |
545 Penobscot Drive | Redwood City | CA | 94063 |
| K040232 | LSI SOLUTIONS |
7796 VICTOR-MENDON RD. | VICTOR | NY | 14564 |
| K050150 | MANI, INC. |
1301 K STREET, N.W. | WASHINGTON | DC | 20005 |
| K961025 | MEDICINE LODGE, INC. |
819 STRIKER AVE., SUITE 10 | SACRAMENTO | CA | 95834-5432 |
| K181182 | Medos International SARL |
Chemin-Blanc 38, Case Postale | Le Locle | CH 2400 | |
| K203186 | Medos International SARL |
Chemin-Blanc 38, Case Postale | Le Locle | CH 2400 | |
| K220219 | Medos International SARL |
Chemin-Blanc 38, Case Postale | Le Locle | CH 2400 | |
| K162247 | MEDOS INTERNATIONAL SARL |
CHEMIN-BLANC 38 | LE LOCLE NEUCHATEL | 2400 | |
| K161638 | MEDOS INTERNATIONAL SARL |
CHEMIN-BLANC 38 | LE LOCLE NEUCHATEL | 2400 | |
| K151758 | MEDTRONIC XOMED INC. |
6743 SOUTHPOINT DRIVE NORTH | JACKSONVILLE | FL | 32216 |
| K053339 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET | EDISON | NJ | 08837 |
| K042038 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
9109 COPENHAVER DRIVE | POTOMAC | MD | 20854 |
| K181633 | Musculoskeletal Transplant Foundation |
125 May Street | Edison | NJ | 08837 |
| K073651 | NEOTRACT, INC. |
4473 WILLOW ROAD | PLEASANTON | CA | 94588 |
| K102028 | NEOTRACT, INC. |
4473 WILLOW ROAD | PLEASANTON | CA | 94588 |
| K101252 | NEOTRACT, INC. |
4473 WILLOW ROAD | PLEASANTON | CA | 94588 |
| K042031 | OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924 | SAN JUAN CAPISTRANO | CA | 92675 |
| K060163 | PETERS SURGICAL |
Z.I. LES VIGNES | BOBIGNY | 93013 | |
| K961925 | R.K. MEDICAL, L.L.C. |
ONE LETHBRIDGE PLAZA | MAHWAH | NJ | 07430 |
| K141072 | RESORBA MEDICAL GMBH |
AM FLACHMOOOR 16 | NUREMBERG | 90475 | |
| K190817 | Riverpoint Medical |
825 NE 25th Ave. | Portland | OR | 97232 |
| K100006 | RIVERPOINT MEDICAL |
825 NE 25TH AVE. | PORTLAND | OR | 97232 |
| K153307 | RIVERPOINT MEDICAL |
825 NE 25th Avenue | Portland | OR | 97232 |
| K202242 | Riverpoint Medical, LLC |
825 NE 25th Ave | Portland | OR | 97232 |
| K230036 | RTI Surgical, Inc |
11621 Research Circle | Alachua | FL | 32615 |
| K223122 | S.B.M. SAS (Science & Bio Materials) |
ZI du Monge | Lourdes | 65100 | |
| K060721 | SENTREHEART |
2468 EMBARCADERO WAY | PALO ALTO | CA | 94303 |
| K090385 | SENTREHEART INC. |
2468 EMBARCADERO WAY | PALO ALTO | CA | 94303 |
| K142241 | SENTREHEART INC. |
300 SAGINAW DR | REDWOOD CITY | CA | 94063-0000 |
| K153096 | SentreHEART, Inc. |
300 Saginaw Drive | Redwood City | CA | 94063 |
| K020902 | SERRAL, S.A. DE C.V. |
5251-18 JOHN TYLER HWY, | WILLIAMSBURG | VA | 23185 |
| K231183 | Shandong Haidike Medical Products Co.,Ltd. |
Tianfu Road, Dongcheng District, Shan County | Heze | 274300 | |
| K970416 | SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K040789 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K980155 | SMITH & NEPHEW, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K092508 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K203393 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K984550 | SMITH & NEPHEW, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K052652 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K121861 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K041216 | SMITH & NEPHEW, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K132357 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K132079 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K072322 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K101377 | SMITH & NEWPHEW, INC |
150 MINUTEMAND ROAD | ANDOVER | MA | 01810 |
| K122735 | SORIN GROUP USA INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K150584 | Stryker |
5670 Greenwood Plaza Blvd, Suite 200 | Greenwood Village | CO | 80111 |
| K162310 | Stryker |
5670 Greenwood Plaza Blvd., Suite 200 | Greenwood Village | CO | 80111 |
| K032901 | Stryker Endoscopy |
5900 OPTICAL CT. | SAN JOSE | CA | 95138 |
| K091574 | SUPPLIDORES UNIDOS INTERNACIONALES, S.A. |
PO BOX 97-0132 | COCONUT CREEK | FL | 33067-2366 |
| K082535 | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
60 Middletown Ave | North Haven | CT | 06473 |
| K091016 | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
60 Middletown Ave | North Haven | CT | 06473 |
| K041512 | SUTURES INDIA PRIVATE LIMITED |
118, 3RD PHASE | BANGALORE | 560-058 | |
| K033654 | TELEFLEX MEDICAL |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K040472 | TELEFLEX MEDICAL |
2917 Weck Drive | Research Triangle Park | NC | 27709 |
| K100506 | TELEFLEX MEDICAL |
5307 95TH AVENUE | KENOSHA | WI | 53144 |
| K063778 | TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD | BANNOCKBURN | IL | 60015 |
| K192490 | Teleflex Medical |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K172016 | Teleflex Medical Incorporated |
375 Forbes Boulevard | Mansfield | MA | 02048 |
| K191268 | Teleflex Medical Incorporated |
375 Forbes Boulevard | Mansfield | MA | 02048 |
| K181774 | Teleflex Medical Incorporated |
375 Forbes Boulevard | Mansfield | MA | 02048 |
| K153089 | Teleflex Medical, Inc. |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K070673 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K150438 | TELEFLEX MEDICAL, INC. |
OEM | MANSFIELD | MA | 02048 |
| K153076 | Teleflex Medical, Inc. |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K994000 | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
157 WINDDANCE DR. | CHICAGO | IL | 60046 |
| K042286 | UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY | RIYADH, CENTRAL PROVINCE | 11553 | |
| K972911 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K990952 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K955747 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K102916 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K100251 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K061276 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K093018 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K210675 | Winter Innovations, Inc. |
2450 EJ Chapman Drive, Suite 114 | Knoxville | TN | 37996 |
| K170642 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K171680 | Xiros Ltd |
Springfield House, Whitehouse Lane | Leeds | LS197UE | |
| K002172 | XIROS PLC |
28-30 BLENHEIM TERRACE | LEEDS | LS2 9HD | |
| K192637 | Yunyi (Beijing) Medical Device Co., LTD |
Floor 1-4, Building 4, No. 9 Tianfu Street | Beijing | 102600 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
