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Taewoong Medical Co., Ltd. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Sphincterotome510(k)May 21, 2026Gastroenterology, Urology
Niti-S SPAXUS Stent510(k)Mar 13, 2026Gastroenterology, Urology
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent510(k)Dec 29, 2025Gastroenterology, Urology
Niti-S Esophageal Stent; Esophageal TTS Stent510(k)Oct 30, 2025General, Plastic Surgery
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent510(k)Mar 31, 2025General, Plastic Surgery
Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent510(k)Jun 14, 2023General, Plastic Surgery
Niti-S Biliary Speed D Stent510(k)May 26, 2023Gastroenterology, Urology
Optimos™ Cystotome510(k)Apr 5, 2023Gastroenterology, Urology
Esophageal TTS Stent510(k)Jun 22, 2022General, Plastic Surgery
Niti-S Biliary Slim M Stent510(k)Jun 9, 2022Gastroenterology, Urology
Esophageal TTS Stent510(k)Oct 8, 2021General, Plastic Surgery

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