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

MSS 2016-07-06

Easy-Load Lens Delivery System

Applicant Bausch and Lomb, Inc.,

K-Number K161012

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GEX 2016-07-05

PicoWay Laser System

Applicant Syneron Candela Corporation

K-Number K160607

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ILY 2016-07-05

LightStim Professional LED Bed

Applicant Led Intellectual Properties, LLC

K-Number K153399

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LIP 2016-07-05

Lumipulse G TP-N Immunoreaction Cartridge Set

Applicant Fujirebio Diagnostics,Inc.

K-Number K153145

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DYB 2016-07-05

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

Applicant Galt Medical Corp.

K-Number K153533

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ILY 2016-07-05

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System

Applicant Usa Laser Biotech, Inc.

K-Number K160947

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MHX 2016-07-01

IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K161531

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QEW 2016-07-01

INDIGO Aspiration System

Applicant Penumbra, Inc.

K-Number K161523

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FRO 2016-07-01

Sorbact Foam Gentle Border, Sorbact Superabsorbent

Applicant Abigo Medical AB

K-Number K153674

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DPS 2016-07-01

PC ECG

Applicant Edan Instruments, Inc.

K-Number K161302

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NKB 2016-07-01

Expedium Spine System, VIPER and VIPER 2 Systems

Applicant Medos International SARL

K-Number K160904

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KWQ 2016-07-01

Cure Anterior Cervical Plate (ACP) System

Applicant Meditech Spine, LLC

K-Number K160604

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