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

IYO 2020-02-25

SonicEye Dual-Array Ultrasound System

Applicant Sonivate Medical, Inc.

K-Number K192253

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JAK 2020-02-25

uCT 530, uCT 550

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K200016

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DWC 2020-02-25

Heater-Cooler System 3T

Applicant Livanova Deutschland, GmbH

K-Number K191402

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PLF 2020-02-25

Trigon HA Stand-Alone Wedge Fixation System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K193414

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GEX 2020-02-25

Surgical laser fibers

Applicant Quanta System Spa

K-Number K200234

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EBF 2020-02-25

Allcem Veneer APS

Applicant Dentscare Ltda

K-Number K191389

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LLZ 2020-02-25

Ez3D-i /E3

Applicant Ewoosoft Co., Ltd.

K-Number K200178

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KDI 2020-02-24

Aquadex FlexFlow System 2.0

Applicant Chf Solutions, Inc.

K-Number K192756

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KWS 2020-02-24

Alliance Augmented Glenoid

Applicant Zimmer, Inc.

K-Number K193180

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KPO 2020-02-24

NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K191474

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PHX 2020-02-24

DELTA XTEND(TM) Reverse Shoulder System

Applicant Depuy(Ireland)

K-Number K192855

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BSK 2020-02-24

Pylant Monitor

Applicant Kal-Med, LLC

K-Number K191858

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