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

MQB 2019-11-22

EXPD 4343P, EXPD 3643P

Applicant DRTECH Corporation

K-Number K193031

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JEY 2019-11-22

KLS Martin Individual Patient Solutions

Applicant KLS-Martin L.P.

K-Number K191028

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IYN 2019-11-22

6450 Ultrasound system

Applicant Esaote, S.p.A.

K-Number K192157

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HRS 2019-11-22

VariAx Foot

Applicant Stryker GmbH

K-Number K192675

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GDW 2019-11-22

Applied Medical Laparoscopic Linear Cutter

Applicant Applied Medical Resources Corporation

K-Number K190331

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CBF 2019-11-22

Revitalair 430F

Applicant Oxavita Srl

K-Number K171899

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PHX 2019-11-22

SMR TT Augmented Glenoid System

Applicant Lima Corporate S.P.A.

K-Number K191746

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MBI 2019-11-22

Parcus Synd-EZ SS

Applicant Parcus Medical, LLC

K-Number K192964

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LLZ 2019-11-22

Medsynapse Ris Pacs & Medsynapse VNA

Applicant Medsynaptic Private, Ltd.

K-Number K192508

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FDI 2019-11-22

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

Applicant Intelligent Endoscopy

K-Number K190512

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LCX 2019-11-22

INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Applicant Innovita (Tangshan) Biological Technology Co., Ltd.

K-Number K192843

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PSQ 2019-11-22

MatriStem UBM Pericardial Patch

Applicant Acell, Inc.

K-Number K191734

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