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

CAF 2020-07-17

AeroEclipse* ONE BAN

Applicant Trudell Medical International

K-Number K200063

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GCJ 2020-07-17

S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable

Applicant Smith & Nephew

K-Number K201198

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JAK 2020-07-17

SCENARIA View

Applicant Hitachi Healthcare Americas

K-Number K200498

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FMF 2020-07-17

Syringe with safety needle, Safety needle

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K193526

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IZL 2020-07-17

Rover

Applicant Micro-X , Ltd.

K-Number K201488

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LHN 2020-07-17

myQA iON

Applicant Iba Dosimetry GmbH

K-Number K201798

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GDW 2020-07-17

Signia Stapler (with new software)

Applicant Covidien

K-Number K201672

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LLZ 2020-07-17

SuRgical Planner (SRP) BrainStorm

Applicant Surgical Theater, Inc.

K-Number K201465

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FDT 2020-07-17

Ambu Duodeno System

Applicant Ambu Innovation GmbH

K-Number K201098

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FDF 2020-07-17

Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I

Applicant Olympus Medical Systems Corp.

K-Number K192793

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MBH 2020-07-17

LINK TrabecuLink Femoral Cones

Applicant Waldemar Link GmbH & Co. KG

K-Number K201364

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GGP 2020-07-17

Cryocheck Chromogenic Factor VIII

Applicant Precision Biologic

K-Number K193204

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