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

KTT 2020-09-11

Dynex Micro

Applicant Vilex, LLC

K-Number K202143

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LPH 2020-09-11

DePuy PINNACLE Dual Mobility Liner

Applicant Depuy Ireland UC

K-Number K200854

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QDA 2020-09-11

Fitbit ECG App

Applicant Fitbit, Inc.

K-Number K200948

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DWJ 2020-09-11

HotDog Temperature Management Controller

Applicant Augustine Temperature Management

K-Number K201779

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ODP 2020-09-11

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

Applicant Meditech Spine, LLC

K-Number K201506

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NBW 2020-09-11

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System

Applicant Microtech Medical, Inc.

K-Number K193340

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LIT 2020-09-11

SABER .035 PTA Dilatation Catheter

Applicant Cordis Corporation

K-Number K201333

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LLZ 2020-09-11

Aline Ablation Intelligence

Applicant Mirada Medical, Ltd.

K-Number K202297

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MHX 2020-09-11

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K192137

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PNO 2020-09-11

FLEX Vessel Prep System

Applicant Venturemed Group, Inc.

K-Number K202187

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NKB 2020-09-10

CD Horizon™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K201407

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NPM 2020-09-10

DSM Biomedical Dental Bone Graft Plus

Applicant Dsm Biomedical

K-Number K193212

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