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

IYE 2018-04-04

SciMoCa

Applicant Radialogica, LLC

K-Number K180595

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DQA 2018-04-04

Pulse Oximeter

Applicant Shanghai Berry Electronic Tech Co., Ltd.

K-Number K172141

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HIR 2018-04-04

leva Pelvic Floor Trainer

Applicant Renovia, Inc.

K-Number K180637

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LLZ 2018-04-04

SIMPLANT 18

Applicant Dentsply Sirona

K-Number K172239

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MED 2018-04-04

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant Steris Corporations

K-Number K180342

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DQY 2018-04-04

TrapLiner catheter

Applicant Vascular Solutions, Inc.

K-Number K180088

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MSH 2018-04-04

Master-Frank N95 Particulate Respirator

Applicant Master & Frank Enterprise Co., Ltd.

K-Number K172963

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JWY 2018-04-04

Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K180339

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HSB 2018-04-03

PRECICE STRYDE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K180503

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OWI 2018-04-03

LigaPASS

Applicant Medicrea International SA

K-Number K173506

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MQV 2018-04-03

DSM Biomedical Calcium Phosphate Cement

Applicant Kensey Nash Corporation Dba Dsm Biomedical

K-Number K173362

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GEX 2018-04-03

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

Applicant Lumenis, Ltd.

K-Number K180597

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