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

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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NJM 2020-02-21

LightForce Orthodontic System (LFO System)

Applicant Lightforce Orthodontics

K-Number K200148

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DXN 2020-02-21

Upper Arm Blood Pressure Monitor

Applicant Shenzhen Zhengkang Technology Co., Ltd.

K-Number K191894

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DSB 2020-02-21

Cardiac Monitor 1500

Applicant Zynex Medical, Inc.

K-Number K191697

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PGW 2020-02-21

TGS Guidewire and updated Scopis Software

Applicant Stryker Ent

K-Number K193118

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HBL 2020-02-21

DORO LUCENT® iXI and iMRI Headrest System

Applicant Pro Med Instruments GmbH

K-Number K191740

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JAK 2020-02-21

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

Applicant Canon Medical Systems Corporation

K-Number K192832

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QJZ 2020-02-21

Novalung System

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K191407

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DCN 2020-02-21

Tina-quant C-Reactive Protein IV

Applicant Roche Diagnostics Operations (Rdo)

K-Number K192072

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