FDA 510(k)

Bio-MEM Ti Reinforced Membrane

Номер K: K210797 · 2022-08-18

Дата решения2022-08-18

Код продуктаNPK

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Bio-MEM Ti Reinforced Membrane is the device name listed in this FDA 510(k) record. The listed applicant is B&Medi Co., Ltd.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K210797. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Bio-MEM Ti Reinforced Membrane?

Bio-MEM Ti Reinforced Membrane is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is B&Medi Co., Ltd.. The 510(k) number is K210797.

When did Bio-MEM Ti Reinforced Membrane receive FDA 510(k) clearance?

Bio-MEM Ti Reinforced Membrane received FDA 510(k) clearance on 2022-08-18, under 510(k) number K210797.

Who is the listed applicant for Bio-MEM Ti Reinforced Membrane?

The FDA 510(k) record lists B&Medi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bio-MEM Ti Reinforced Membrane?

The FDA product code for Bio-MEM Ti Reinforced Membrane is NPK.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NPK)

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais K222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.