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

LXT 2023-09-22

Para-Fix External Fixation System

Applicant New Paradigm Biomedical

K-Number K230067

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KGN 2023-09-22

MicroMatrix® Flex

Applicant Acell, Inc.

K-Number K230980

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LZA 2023-09-21

Powder-Free Nitrile Examination Gloves

Applicant Global Protection Corp.

K-Number K223214

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OUR 2023-09-21

Integrity-SI® Fusion System

Applicant OsteoCentric Technologies

K-Number K230226

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FOZ 2023-09-21

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

Applicant Poly Medicure Limited

K-Number K231401

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KPI 2023-09-21

Pelvic Floor Muscle Stimulator

Applicant Nanjing Vishee Medical Technology Co., Ltd.

K-Number K230767

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GEI 2023-09-21

BTL-899F

Applicant BTL Industries, Inc.

K-Number K230467

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GWG 2023-09-21

QEVO System

Applicant Carl Zeiss Meditec, AG

K-Number K232159

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KDN 2023-09-21

Servator P Plus SALF Solution

Applicant S.A.L.F. Spa

K-Number K230193

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DYG 2023-09-21

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform

Applicant Edwards Lifesciencess, LLC

K-Number K231248

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FGE 2023-09-21

EGIS Biliary Single Bare Stent

Applicant S&G Biotech, Inc.

K-Number K223354

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HGX 2023-09-21

Smart double sides wearable breast pump, Electric bilateral breast pump

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K-Number K230102

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