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

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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MYN 2023-09-21

Overjet Periapical Radiolucency Assist

Applicant Overjet, Inc.

K-Number K231678

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KPS 2023-09-21

CAREMIBRAIN

Applicant General Equipment For Medical Imaging, S.A.

K-Number K232569

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EOQ 2023-09-20

Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

Applicant Ambu A/S

K-Number K232582

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