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

FFX 2018-11-15

SITZMARKS

Applicant Konsyl Pharmaceuticals

K-Number K181750

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NLH 2018-11-15

Reprocessed Marinr Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K181897

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FZP 2018-11-15

Amsel Endo Occluder

Applicant Amsel Medical Corporation

K-Number K180650

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FCG 2018-11-15

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

Applicant Olympus Medical Systems Corp.

K-Number K180668

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IOR 2018-11-14

Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs

Applicant Invacare Corporation

K-Number K181090

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MAX 2018-11-14

Velofix TLIF Cage

Applicant U&I Corporation

K-Number K181829

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DQY 2018-11-14

React 71 Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K182097

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EBF 2018-11-14

Apoller Flow Light Cure Flowable Composite

Applicant Greenway Yw, LLC

K-Number K180463

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IYN 2018-11-14

Z6 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K182603

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HRX 2018-11-14

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control

Applicant Conmed Corporation

K-Number K182882

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FRC 2018-11-14

SporView Rapid Read Biological Indicator SteamPlus Test Pack

Applicant Crosstex/Spsmedical, A Division of Cantel Medical

K-Number K181434

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DZE 2018-11-14

Inversa Implants

Applicant Southern Implants (Pty), Ltd.

K-Number K181850

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