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

IYN 2019-09-06

Lumify Diagnostic Ultrasound System

Applicant Philips Health Care

K-Number K192226

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DQK 2019-09-06

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K191392

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GEX 2019-09-06

EVO Platform

Applicant Quanta System Spa

K-Number K192160

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GEI 2019-09-06

Venus Legacy Pro Device

Applicant Venus Concept USA, Inc.

K-Number K191528

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EOB 2019-09-06

Rhino-Laryngo Videoscope Olympus ENF-VT3

Applicant Olympus Medical Systems Corp.

K-Number K183416

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HGX 2019-09-06

Willow Wearable Breast Pump 2.0

Applicant Exploramed Nc7, Inc.

K-Number K191577

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GEI 2019-09-06

Secret RF Smartcure Applicator with electrodes

Applicant Ilooda Co,., Ltd.

K-Number K182355

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PSV 2019-09-06

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

Applicant Olympus Medical Systems Corp.

K-Number K183525

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FLL 2019-09-06

Reusable Temperature Probe

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K182751

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GZF 2019-09-06

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

Applicant Nalu Medical, Inc.

K-Number K191435

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HAW 2019-09-06

Microscope Navigation

Applicant Brainlab AG

K-Number K190250

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PGY 2019-09-06

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

Applicant Barco N.V.

K-Number K191845

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