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

NGX 2018-06-14

BTL 799-2

Applicant BTL Industries, Inc.

K-Number K180813

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NBW 2018-06-14

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K-Number K181316

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MUI 2018-06-13

EcoVue Sterile and Non-Sterile Ultrasound Gels

Applicant H R Pharmaceuticals, Inc.

K-Number K181363

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MQB 2018-06-13

PEDRA-17F Digital Flat Panel X-ray Detector

Applicant Radisen, Inc.

K-Number K180989

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KCT 2018-06-13

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

Applicant Case Medical, Inc.

K-Number K173259

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ELW 2018-06-13

PEAK NS033CF, PEAK NS017CF

Applicant Neosil Co., Ltd.

K-Number K180565

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NJM 2018-06-13

Signature Orthodontic System

Applicant Signature Orthodontics

K-Number K181271

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LYZ 2018-06-13

Vinyl Examination Glove (Clear, Non-Colored)

Applicant Zhicheng Trading Co., Ltd.

K-Number K180861

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OWP 2018-06-13

VERIFY Assert Self-Contained Biological Indicator

Applicant STERIS Corporation

K-Number K181442

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KPR 2018-06-13

Ysio Max

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K181279

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JAK 2018-06-13

HealthCCS

Applicant Zebra Medical Vision, Ltd.

K-Number K172983

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OUR 2018-06-13

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Applicant Tenon Medical, Inc.

K-Number K180818

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