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

DPS 2017-12-15

ECG Acquisition Systems

Applicant Vales & Hills Biomedical Tech. , Ltd.

K-Number K163607

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DXN 2017-12-15

V10

Applicant Mediana Co., Ltd.

K-Number K170497

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OTO 2017-12-15

Polyform Synthetic Mesh

Applicant Boston Scientific Corporation

K-Number K171271

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NKG 2017-12-15

Proficient® Posterior Cervical Spine System

Applicant Spine Wave, Inc.

K-Number K172594

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DQA 2017-12-15

The Nellcor pulse oximetry monitor interface cable

Applicant Covidien

K-Number K172482

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LYA 2017-12-15

Composite Removable Sinus Stent System

Applicant Sts Medical

K-Number K170913

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DXH 2017-12-15

BioFlux Device

Applicant Biotricity, Inc.

K-Number K172311

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LIT 2017-12-15

PROTEUS PTA Balloon Catheter with Embolic Capture Feature

Applicant Angioslide, Ltd.

K-Number K172494

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MQE 2017-12-15

Double Lumen Ovum Aspiration Needles

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K171611

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HRS 2017-12-15

AxSOS 3 Ti

Applicant Stryker GmbH

K-Number K172350

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LYZ 2017-12-15

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Anhui Kindguard Medical Supplies Technology Co., Ltd.

K-Number K173017

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MQV 2017-12-15

ReBOSSIS85

Applicant Orthorebirth Co., Ltd.

K-Number K172573

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