Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HET 2021-10-13

Video Endoscopy System, 3D Video Endoscopy System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K210116

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NRY 2021-10-13

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

Applicant Neuravi, Ltd.

K-Number K212908

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NHI 2021-10-13

SPRINT PNS System

Applicant Spr Therapeutics, Inc.

K-Number K211801

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KIF 2021-10-13

UltraCal XS

Applicant Ultradent Products, Inc.

K-Number K211905

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HSX 2021-10-12

BC Reflex Uni Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K212307

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QHE 2021-10-12

Signature ONE System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K212560

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QKB 2021-10-12

VBrain-OAR

Applicant Vysioneer, Inc.

K-Number K212116

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LZA 2021-10-12

Nitrile examination gloves

Applicant Fitone Latex Products Co., Ltd. Guangdong

K-Number K211927

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FXX 2021-10-12

Disposable Surgical Mask (Model: YYKZ-01)

Applicant Jiaxing Amazing Travel-Ware Co., Ltd.

K-Number K210845

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OVE 2021-10-12

Idys-C ZP 3DTi

Applicant Clariance, SA

K-Number K212562

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KTT 2021-10-12

Correx Software

Applicant Vilex, LLC

K-Number K212552

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OXZ 2021-10-10

Child Face Mask

Applicant Shandong Shengquan New Material Co., Ltd.

K-Number K201514

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