Data / Medical devices / Retention Device, Suture
Retention Device, Suture (KGS): 53 FDA-registered makers in 9 countries
53 establishments in 9 countries are registered with the FDA to make Retention Device, Suture (product code KGS, Class 1, 21 CFR 878.4930). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on January 28, 2003, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGS
- Device class
- 1
- Regulation
- 878.4930
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 34 |
| Pakistan | 4 |
| Mexico | 4 |
| Germany | 3 |
| Switzerland | 3 |
| South Korea | 2 |
| Costa Rica | 1 |
| Canada | 1 |
| China | 1 |
Makers of Retention Device, Suture
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | March 23, 1982 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 1 | February 27, 1989 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Charlotte | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrocare Corporation | Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conextions Inc | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Catheter Precision, Incorporated | Fort Mill, SC, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRS Vascular, Inc. | San Jose, CA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Dufner Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gynamed Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Line International Corporation | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implantech Associates, Inc. | Ventura, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imt Inc. | Gwangju, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inot Co., Ltd. | Uiwang Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inari Medical, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Melpex Beauty Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Orthopedics Inc. | Arlington, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preservation Solutions, Inc. | Elkhorn, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suturegard Medical, Inc. | Corvallis, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesco Associates, Inc. | Tyngsboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziptek LLC | Sarasota, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 28, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.