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

DTZ 2020-06-12

INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

Applicant Sorin Group Italia S.R.L.

K-Number K200683

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OLO 2020-06-12

REAL INTELLIGENCE CORI (CORI)

Applicant Blue Belt Technologies, Inc.

K-Number K201022

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NUH 2020-06-12

Electrical Stimulator System

Applicant Gymmax Technology Shenzen Co., Ltd.

K-Number K192201

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IYE 2020-06-11

Gold Anchor

Applicant Naslund Medical AB

K-Number K201117

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LLZ 2020-06-11

uWS-MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K192630

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DQY 2020-06-11

Benchmark BMX96 Access System

Applicant Penumbra, Inc.

K-Number K201271

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ONF 2020-06-11

E>EyeC

Applicant E-Swin

K-Number K200616

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IYN 2020-06-11

Versana Active

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200998

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ODP 2020-06-11

RIGEL 3DR Anterior Cervical Interbody Fusion System

Applicant MiRus, LLC

K-Number K200685

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EZN 2020-06-11

In-Ka Ureteral Balloon Dilatation Catheter

Applicant Coloplast Corp.

K-Number K201007

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DPS 2020-06-11

physIQ Heart Rhythm and Respiration Module

Applicant Physiq, Inc.

K-Number K193415

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IYO 2020-06-11

Auto 3D Bladder Volume Tool

Applicant Butterfly Network, Inc.

K-Number K200980

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