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

JOW 2016-11-03

Intermittent Pneumatic Compression system

Applicant Daesung Maref Co., Ltd.

K-Number K160180

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FOZ 2016-11-03

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

Applicant Medsource International, LLC

K-Number K161779

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OMP 2016-11-03

Avance Gauze Dressing Kits

Applicant Molnlycke Health Care Us, LLC

K-Number K161948

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DXN 2016-11-03

Electronic Sphygmomanometer

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K160349

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MAI 2016-11-03

Nanova Interference Screw

Applicant Nanova Biomaterials, Inc.

K-Number K161174

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FMI 2016-11-03

Greiner Holdex

Applicant Greiner Bio-One Na, Inc.

K-Number K160532

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OKS 2016-11-03

Nunchaku

Applicant Fci (France Chirurgie Instrumentation)

K-Number K161373

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NKG 2016-11-03

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K162136

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HRS 2016-11-03

MatrixRIB Fixation System

Applicant Synthes (USA) Products, LLC

K-Number K161590

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MUH 2016-11-03

FONA Pan/Ceph

Applicant Fona S.R.L

K-Number K161131

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MNH 2016-11-03

CastleLoc Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K162801

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MUE 2016-11-03

Senographe Pristina

Applicant GE Healthcare

K-Number K162268

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