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

FLL 2019-10-18

Infrared Thermometer, Breeze model

Applicant Suzhou Melodicare Medical Technology Co., Ltd.

K-Number K191283

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LGZ 2019-10-18

Quantum Blood and Fluid Warming System

Applicant Life Warmer, Inc.

K-Number K192325

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MXC 2019-10-18

Confirm Rx Insertable Cardiac Monitor

Applicant Abbott

K-Number K192593

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BZD 2019-10-18

Care Orchestrator Essence

Applicant Respironics, Inc.

K-Number K183226

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LNH 2019-10-18

RTHawk, HeartVista Cardiac Package

Applicant Heartvista, Inc.

K-Number K183274

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QEY 2019-10-18

Bashir S-B Endovascular Catheter, Ref. No. 7101

Applicant Thrombolex, Inc.

K-Number K192598

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LLZ 2019-10-18

Synapse 3D Blood Flow Analysis

Applicant Fujifilm Corporation

K-Number K191544

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MNR 2019-10-18

SomnaPatch

Applicant Respironics, Inc.

K-Number K183625

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OLO 2019-10-18

SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set

Applicant Medos International SARL

K-Number K191943

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EGJ 2019-10-18

Saalio

Applicant Saalmann Medical GmbH & Co. KG

K-Number K191436

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FRO 2019-10-18

BIAFINE Topical Cream

Applicant Bausch Health Americas Incorporated

K-Number K190342

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HGX 2019-10-18

Evolve Breast Pump

Applicant Hygeia II Medical Group, Inc.

K-Number K190465

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