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

DQX 2018-04-11

Inno-Hydrowire

Applicant Suzhou Innomed Medical Device Co., Ltd.

K-Number K172187

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IYO 2018-04-11

s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

Applicant Volcano Corporation

K-Number K173860

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MQV 2018-04-11

Rafugen DBM

Applicant Cellumed Co., Ltd.

K-Number K180121

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NKG 2018-04-11

Reform® POCT System

Applicant Precision Spine, Inc.

K-Number K172495

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KYI 2018-04-11

Stablyx CMC Arthroplasty Implant System

Applicant Skeletal Dynamics, LLC

K-Number K180744

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MEH 2018-04-11

Corin TriFit CF Hip Stem

Applicant Corin U.S.A. Limited

K-Number K173880

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KPS 2018-04-11

PET Digital Gating

Applicant Ge Medical Systems, LLC

K-Number K180318

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MAI 2018-04-11

HEALIX ADVANCE Anchor with DYNACORD Suture

Applicant Medos International SARL

K-Number K173859

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PHR 2018-04-11

Riva Star

Applicant Sdi Limited

K-Number K172047

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MQF 2018-04-11

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

Applicant Cook Incorporated

K-Number K173686

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LPL 2018-04-10

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K180398

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NKB 2018-04-10

Mercury® Spinal System

Applicant Spinal Elements, Inc.

K-Number K172967

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