Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FXX 2021-10-04

Private Stock Labs Surgical Face Mask

Applicant J.K. Private Stock, Inc.

K-Number K211425

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LLZ 2021-10-04

EzDent-i/ E2/ Prora View/ Smart M Viewer

Applicant Ewoosoft Co., Ltd.

K-Number K211795

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FXX 2021-10-04

Surgical Face Mask

Applicant Hubei Yi-Ya Protective Products Co., Ltd.

K-Number K211899

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EIH 2021-10-04

INNI-CERA

Applicant Aon Co., Ltd.

K-Number K211308

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MQV 2021-10-04

Dry DBM- A Putty

Applicant Seaspine Corporation

K-Number K212135

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NUH 2021-10-04

Smart Neck Stimulator

Applicant Guandong Skg Intelligent Technology Co., Ltd.

K-Number K200558

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DYB 2021-10-04

Prelude Guide Sheath

Applicant Merit Medical Systems, Inc.

K-Number K211405

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IRP 2021-10-04

RecoveryAir PRO

Applicant Theragun, Inc.

K-Number K211745

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NBC 2021-10-04

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K201312

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ONF 2021-10-04

IPL Hair Remover, Model: G993, G996, G998 and G885

Applicant Shenzhen Mywin Technology Co., Ltd.

K-Number K211368

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QEA 2021-10-02

EYE-SYNC

Applicant Syncthink, Inc.

K-Number K202927

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GYC 2021-10-02

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

Applicant Dixi Medical

K-Number K201931

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