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

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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NBY 2018-10-11

DemeTECH PTFE Nonabsorbable Surgical Suture

Applicant Demetech Corporation

K-Number K181578

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KGN 2018-10-11

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K-Number K181330

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GEI 2018-10-11

Voyant Electrosurgical Generator

Applicant Applied Medical Resources Corp.

K-Number K182244

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NXC 2018-10-11

Ormco Spark Aligner System

Applicant Sybron Dental Specialties

K-Number K182826

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NHA 2018-10-11

Sirona Dental CAD/CAM System

Applicant Dentsply Sirona

K-Number K181520

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