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

MRX 2020-03-25

LaserShot M, NaviLase

Applicant Vitrolife GmbH

K-Number K192008

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BZH 2020-03-25

Aluna

Applicant Knox Medical Diagnostics, Inc.

K-Number K193311

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EBF 2020-03-25

DiaFil Flow

Applicant DiaDent Group International

K-Number K192284

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HHK 2020-03-25

CrossBay Endometrial Tissue Sampler (ETS)

Applicant Crossbay Medical

K-Number K192534

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NEW 2020-03-25

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

Applicant ETHICON, Inc.

K-Number K192144

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QIH 2020-03-25

Arterys MICA

Applicant Arterys, Inc.

K-Number K192437

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DXQ 2020-03-25

Disposable NIBP Cuff

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K193629

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OVD 2020-03-25

NuVasive 3DP Interfixated ALIF System

Applicant Nu Vasive, Incorporated

K-Number K193593

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PHX 2020-03-25

Medacta Shoulder System

Applicant Medacta International S.A.

K-Number K192967

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NKG 2020-03-25

NorthStar™ OCT Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K193615

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JAK 2020-03-25

syngo.CT Cardiac Planning

Applicant Siemens Medical Soultions USA, Inc.

K-Number K200515

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OAP 2020-03-25

Shapiro MD model laser 272

Applicant Conversion Labs, Pr, LLC

K-Number K193667

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