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

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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NXC 2020-02-24

3D Predict

Applicant 3D Smile USA, Inc.

K-Number K200214

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PLR 2020-02-24

NEXXT MATRIXX System

Applicant Nexxt Spine, LLC

K-Number K193412

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HWC 2020-02-24

Titanium Interference Screws

Applicant Biomet, Inc.

K-Number K193451

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HSB 2020-02-23

T2 Alpha Tibia Nailing System, IMN Screws System

Applicant Stryker Trauma GmbH

K-Number K193308

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OYV 2020-02-21

AmplideX Fragile X Dx & Carrier Screen Kit

Applicant Asuragen, Inc.

K-Number DEN190023

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NJM 2020-02-21

LightForce Orthodontic System (LFO System)

Applicant Lightforce Orthodontics

K-Number K200148

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