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

EOB 2019-07-12

Ambu aScope 4 RhinoLaryngo Intervention

Applicant Ambu A/S

K-Number K190972

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KPS 2019-07-12

VERITON CT whole body SPECT/CT system

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K190457

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JOW 2019-07-12

Radial Medical Compression System

Applicant Radial Medical, Inc.

K-Number K190976

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MSX 2019-07-12

Wearable Device, Wearable Package

Applicant Current Health , Ltd.

K-Number K191272

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GEI 2019-07-12

Valleylab FT10 Electrosurgical Platform

Applicant Covidien

K-Number K191601

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LLZ 2019-07-12

iNtuition-Structural Heart Module

Applicant Terarecon,Inc.

K-Number K191585

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GEX 2019-07-12

PerioLase Nd:YAG Pulsed Dental Laser System

Applicant Millennium Dental Technologies, Inc.

K-Number K182930

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KNW 2019-07-12

Remington Medical, Inc. Automatic Cutting Needle (NAC)

Applicant Remington Medical, Inc.

K-Number K191315

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NGT 2019-07-12

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

Applicant Amsino International, Inc.

K-Number K183473

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EBF 2019-07-12

Novidia Bulk Fill Flow Composite

Applicant Nobio , Ltd.

K-Number K182714

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NBY 2019-07-12

StitchKit

Applicant Origami Surgical

K-Number K191317

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NAY 2019-07-12

SureForm 45 Curved Tip, SureForm 45 Gray Reload

Applicant Intuitive Surgical, Inc.

K-Number K190999

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