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

KWQ 2018-06-22

Life Spine Lumbar Fixation System (SENTRY)

Applicant Life Spine, Inc.

K-Number K180166

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KTN 2018-06-22

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

Applicant SEKISUI Diagnostics, LLC

K-Number K181436

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LEJ 2018-06-22

FIJI SUN FLUORESCENT TANNING UNIT

Applicant Kdb Inc. (Dba) Sperti Sunlamp

K-Number K151721

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MOI 2018-06-22

Elecsys CA 15-3 II

Applicant Roche Diagnostics

K-Number K181492

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GBM 2018-06-22

VaPro 2 Intermittent Catheter

Applicant Hollister Incorporated

K-Number K180824

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KRD 2018-06-22

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

Applicant Shape Memory Medical

K-Number K181051

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JOW 2018-06-22

AIROS 8 Sequential Compression Device

Applicant Airos Medical, Inc.

K-Number K172779

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IYO 2018-06-22

Shear Wave Quantificational Ultrasound Diagnostic System

Applicant Wuxi Hisky Medical Technologies Co., Ltd.

K-Number K173595

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KDN 2018-06-22

Perfadex Plus

Applicant Xvivo Perfusion AB

K-Number K170826

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JWH 2018-06-22

A3 Total Knee System

Applicant Beijing AK Medical Co., Ltd.

K-Number K180493

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LEJ 2018-06-22

UV Lamps for Sunlamp Products

Applicant Feilo Sylvania Germany GmbH

K-Number K180581

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DTZ 2018-06-22

Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

Applicant Terumo Cardiovascular Systems Corporation

K-Number K180950

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