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

MSV 2018-06-25

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

Applicant Phadia AB

K-Number K181329

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OVB 2018-06-25

SpaceOAR System

Applicant Augmenix, Inc.

K-Number K181465

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NUH 2018-06-22

Wireless Pain Relieve Device

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K180331

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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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PQK 2018-06-22

everlinQ endoAVF System

Applicant Tva Medical, Inc.

K-Number DEN160006

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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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