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

OLO 2020-09-16

Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set

Applicant Medos International SARL

K-Number K201661

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HSB 2020-09-16

Precice® Ankle Salvage System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K200430

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DQK 2020-09-16

VX1

Applicant Volta Medical

K-Number K201298

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KGO 2020-09-16

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

Applicant Pt. Medisafe Technologies

K-Number K201774

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LLZ 2020-09-16

AVA (Augmented Vascular Analysis)

Applicant See-Mode Technologies Pte, Ltd.

K-Number K201369

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OAS 2020-09-16

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

Applicant Genoray Co., Ltd.

K-Number K200469

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KPR 2020-09-16

EOSedge

Applicant Eos Imaging

K-Number K202394

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IYN 2020-09-16

Butterfly iQ Ultrasound System

Applicant Butterfly Network, Inc.

K-Number K202406

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PRH 2020-09-15

Accelerate Pheno System, Accelerate PhenoTest BC Kit

Applicant Accelerate Diagnostics, Inc.

K-Number K192665

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MTD 2020-09-15

AcQMap 3D Imaging and Mapping Catheter

Applicant Acutus Medical, Inc.

K-Number K201341

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OUR 2020-09-15

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K201664

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LIT 2020-09-15

Athletis PTA Balloon Dilatation Catheter

Applicant Boston Scientific Corporation

K-Number K201170

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