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

LPL 2018-09-06

Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens

Applicant Gelflex Laboratories

K-Number K181558

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IZL 2018-09-06

Optima XR240amx

Applicant Ge Medical Systems, LLC

K-Number K182234

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BZQ 2018-09-05

Masimo Acoustic Respiration Sensors, infant and neonate

Applicant Masimo Corporation

K-Number K173976

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IYE 2018-09-05

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

Applicant Eleckta Limited

K-Number K182138

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GEX 2018-09-05

Iridex TruFocus LIO Premiere

Applicant Iridex Corporation

K-Number K181662

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FPA 2018-09-05

AMSafe Sure-Lok Needle-Free Connector

Applicant Amsino International, Inc.

K-Number K173665

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NWB 2018-09-05

HD-500 Video Endoscope System

Applicant Sonoscape Medical Corp.

K-Number K173921

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OAP 2018-09-05

Kiierr 272 Laser, Kiierr 148 Laser

Applicant Kiierr International, LLC

K-Number K181878

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MHX 2018-09-04

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K181314

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EZL 2018-09-04

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

Applicant Amsino International, Inc.

K-Number K181814

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GEI 2018-09-04

EUSRA RF Electrode

Applicant Starmed Co., Ltd.

K-Number K181249

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GEX 2018-09-04

ECHOLASER X4

Applicant El.En Electronic Engineering Spa

K-Number K181510

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