FDA 510(k) Applications for Medical Device:
Suture, Nonabsorbable, Synthetic, Polyamide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K151165 | AESCULAP, INC. |
3773 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034 |
| K060528 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K990090 | AESCULAP, INC. |
13221 MARICOTTE PLACE | SAN DIEGO | CA | 92130 |
| K212888 | Antarma LLC dba Golnit Sutures |
276 5th Ave., Suite 704 | New York | NY | 10001 |
| K000539 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. | SYOSSET | NY | 11791 |
| K042367 | AROS SURGICAL INSTRUMENTS CORP. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K032160 | ARTIMPLANT AB |
719 A STREET NE | WASHINGTON | DC | 20002 |
| K052482 | ARTIMPLANT AB |
719 A STREET NE | WASHINGTON | DC | 20002 |
| K024090 | AUROLAB |
6441 ENTERPRISE LN. | MADISON | WI | 53719 |
| K001173 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K981582 | DAVIS & GECK, INC. |
444 MC DONNELL BLVD. | HAZELWOOD | MO | 63042 |
| K023028 | DEMETECH CORP. |
12119 SW 131 AVE. | MIAMI | FL | 33186 |
| K060471 | FSSB CHIRURGISCHE NADELN GMBH |
719 A STREET, NE. | WASHINGTON | DC | 20002 |
| K981322 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K003000 | GRAMSMED LLC |
2225 DAKOTA DR. | GRAFTON | WI | 53024 |
| K192420 | Kono Seisakusho Co., Ltd. |
3-43-16, Hongo | Bunkyo-ku | 130-0033 | |
| K053637 | MANI, INC. |
1301K STREET, N.W. | WASHINGTON | DC | 20005-3373 |
| K993970 | MICRINS SURGICAL, INC. |
28438 BALLARD DR. | LAKE FOREST | IL | 60045 |
| K081366 | NASHVILLE SURGICAL INSTRUMENTS |
2005 KUMAR LANE | SPRINGFIELD | TN | 37172 |
| K052900 | QUILL MEDICAL, INC. |
2505 MERIDIAN PARKWAY | RESEARCH TRIANGLE PARK | NC | 27713 |
| K960327 | R.K. MEDICAL, L.L.C. |
ONE LETHBRIDGE PLAZA | MAHWAH | NJ | 07430 |
| K152795 | RIVERPOINT MEDICAL |
825 NE 25TH AVENUE | PORTLAND | OR | 97232 |
| K031531 | S & T AG |
28438 BALLARD DR. | LAKE FOREST | IL | 60045 |
| K020146 | SERRAL, S.A. DE C.V. |
5251-18 JOHN TYLER HWY, | WILLIAMSBURG | VA | 23185 |
| K212603 | Shandong Haidike Medical Product Co., Ltd. |
Tianfu Road, Dongcheng District, Shan County | Heze | 274300 | |
| K161633 | SM ENG CO., LTD |
46, NAKDONG-DAERO 1302BEON-GIL | SASANG-GU | ||
| K030177 | SRI ORION PHARMACEUTICALS & SUTURES |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K041510 | SUTURES INDIA PRIVATE LIMITED |
118, 3RD PHASE | BANGALORE | 560-058 | |
| K220980 | TAS Medical, Inc. |
1100 Industrial Road | San Carlos | CA | 94070 |
| K993998 | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
157 WINDDANCE DR. | CHICAGO | IL | 60046 |
| K123034 | UNILENE S.A.C. |
33 Golden Eagle Lane | Littleton | CO | 80127 |
| K042284 | UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY | RIYADH, CENTRAL PROVINCE | 11553 | |
| K994176 | VISIONARY MEDICAL SUPPLIES, INC. |
4740 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20008 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
