Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
KGS
Device class
1
Regulation
878.4930
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States34
Pakistan4
Mexico4
Germany3
Switzerland3
South Korea2
Costa Rica1
Canada1
China1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biomet, Inc.Warsaw, IN, United StatesManufacturer1March 23, 1982000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1February 27, 1989000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aptyx - CharlotteCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Boston Medical Products, Inc.Shrewsbury, MA, United StatesManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Catheter Precision, IncorporatedFort Mill, SC, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
DRS Vascular, Inc.San Jose, CA, United StatesManufacturer, Specification developer0010api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gynamed InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Implantech Associates, Inc.Ventura, CA, United StatesContract manufacturer0000api.fda.gov
Imt Inc.Gwangju, South KoreaManufacturer0000api.fda.gov
Inot Co., Ltd.Uiwang Gyeonggi, South KoreaManufacturer0000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Preservation Solutions, Inc.Elkhorn, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Southmedic, Inc.BARRIE Ontario, CanadaManufacturer0000api.fda.gov
Suturegard Medical, Inc.Corvallis, OR, United StatesSpecification developer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ziptek LLCSarasota, FL, United StatesSpecification developer0000api.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.