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

LWM 2020-01-17

Dental Pain Eraser

Applicant Synapse Dental

K-Number K193570

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DSA 2020-01-17

SureLead Cable System

Applicant Authentic Medical

K-Number K181089

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DXH 2020-01-17

Study Watch with Irregular Pulse Monitor

Applicant Verily Life Sciences, LLC

K-Number K192415

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MPB 2020-01-17

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

Applicant Covidien, LLC

K-Number K192302

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LZA 2020-01-17

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K192635

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GYB 2020-01-17

SAC2 - Electrode Cream

Applicant Spes Medica Srl

K-Number K192606

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HIH 2020-01-17

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

Applicant Lina Medical Aps

K-Number K193007

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DYB 2020-01-17

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

Applicant Acutus Medical, Inc.

K-Number K193509

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CCK 2020-01-17

Altera gas Sampling Lines

Applicant Meditera Tibbi Malzeme San VE Tic AS

K-Number K192563

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OLO 2020-01-17

Black Diamond Navigation Instruments

Applicant Osseus Fusion Systems

K-Number K192495

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PDU 2020-01-17

SoundBite Console, SoundBite Active Wire 18

Applicant Soundbite Medical Solution, Inc.

K-Number K192211

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NBW 2020-01-17

CareSens S Fit BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K193590

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