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

EBI 2016-09-02

JET SET 4 DENTURE REPAIR RESIN

Applicant Lang Dental Manufacturing Company, Inc.

K-Number K152981

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LLZ 2016-09-02

Restore PACS

Applicant Xian Wingspan Electronic Technology Co., Ltd.

K-Number K162141

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LLZ 2016-09-02

PROcedure Rehearsal Studio

Applicant 3Dsystems, Simbionix Products

K-Number K153705

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JPK 2016-09-01

BC-5D Hematology Control

Applicant R&D Systems, Inc.

K-Number K160606

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MQB 2016-09-01

CareView 1500P X-ray Flat Panel Detectors

Applicant Careray Digital Medical System Co., Ltd.

K-Number K162178

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LJS 2016-09-01

Cathtong I PICC Catheter

Applicant L&Z Us, Inc.

K-Number K153469

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PNR 2016-09-01

Monoject Enteral Syringe with ENFit Connector

Applicant Covidien

K-Number K161963

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JPA 2016-09-01

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K161312

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LRK 2016-09-01

Noiselezz

Applicant Firma Ingemarsson

K-Number K160531

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ONF 2016-09-01

DUO

Applicant Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd

K-Number K161565

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MQB 2016-09-01

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

Applicant Perkinelmer, Inc.

K-Number K161942

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FRN 2016-09-01

Concert Medical Hands-Free Syringe (HFS)

Applicant Concert Medical, LLC

K-Number K153599

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