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

GEI 2018-10-12

Percuvance Percutaneous Surgical System

Applicant Teleflexmedical, Inc.

K-Number K181852

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JDQ 2018-10-12

Thorecon Rigid Fixation System

Applicant A & E Medical Corporation

K-Number K181607

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NQW 2018-10-12

Life Spine Laminoplasty System

Applicant Life Spine, Inc.

K-Number K181717

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BSK 2018-10-12

AG 100s

Applicant Hospitech Respiration , Ltd.

K-Number K180991

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DCN 2018-10-12

Optilite High Sensitivity C-Reactive Protein Kit

Applicant The Binding Site Group , Ltd.

K-Number K180099

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FDS 2018-10-12

PENTAX Video Upper G.I. Scope EG34-i10

Applicant Pentax Medical of America, Inc.

K-Number K180292

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PHX 2018-10-12

Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap

Applicant Exactech, Inc.

K-Number K182536

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PNR 2018-10-11

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K-Number K181426

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HRS 2018-10-11

Piccolo Composite® Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K182015

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EKX 2018-10-11

LS OIL

Applicant J. Morita USA, Inc.

K-Number K173920

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IYN 2018-10-11

E-CUBE 8

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K181617

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DQA 2018-10-11

Fingertip Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K181503

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