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

PNO 2020-04-15

Serranator PTA Serration Balloon Catheter

Applicant Cagent Vascular, LLC

K-Number K193181

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MUH 2020-04-15

I-View Gold and Imagen Gold Dental Sensors

Applicant Trident S.R.L

K-Number K200625

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PHX 2020-04-15

Comprehensive® Reverse Shoulder

Applicant Biomet, Inc.

K-Number K193373

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FRA 2020-04-15

Molekule Air Pro RX

Applicant Molekule, Inc.

K-Number K200500

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FRC 2020-04-15

3MTM AttestTM Mini Auto-reader 490M

Applicant 3M

K-Number K200092

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EOQ 2020-04-15

Monarch Platform

Applicant Auris Health, Inc.

K-Number K193534

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IYN 2020-04-15

ACUSON Sequoia Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200707

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GCJ 2020-04-15

7 mm Extended Length Endoscope

Applicant Maquet Cardiovascular, LLC

K-Number K191930

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MAX 2020-04-15

Tritanium® X TL Expandable Curved Posterior Lumbar Cage

Applicant Stryker Corporation

K-Number K200613

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NUC 2020-04-14

KY Grosz UltraGel

Applicant Rb Health (Us), LLC

K-Number K192982

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OCX 2020-04-14

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

Applicant Ga Health Company Limited

K-Number K200388

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ITI 2020-04-14

Solax Powered Wheelchair (Models: S7101, S7103)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K182400

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