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

QIH 2023-07-21

OptimMRI

Applicant Rebrain, Sas

K-Number K230150

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LOX 2023-07-21

Firefighter™ NC Pro PTCA Balloon Catheter

Applicant Shanghai MicroPort Medical (Group) Co., Ltd.

K-Number K223189

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HAW 2023-07-21

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Applicant Brainlab AG

K-Number K223288

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NBC 2023-07-21

Elecsys proBNP II, Elecsys proBNP II STAT

Applicant Roche Diagnostics

K-Number K223637

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FFX 2023-07-21

EndoflipTM 300 System

Applicant Covidien, LLC

K-Number K231861

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PQC 2023-07-21

MySpine Unilateral Guides

Applicant Medacta International S.A.

K-Number K231483

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NZA 2023-07-21

enspire 300 Series Automated Endoscope Reprocessor System

Applicant STERIS Corporation

K-Number K230560

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PWH 2023-07-21

BD Alaris™ Pump Epidural Infusion Set

Applicant Care Fusion

K-Number K221319

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MBF 2023-07-21

INHANCE™ Shoulder System, Sterile Single Use Instrumentation

Applicant Depuy Ireland UC

K-Number K231516

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OWB 2023-07-20

Oscar 15 & Oscar 15i

Applicant Genoray Co., Ltd.

K-Number K230787

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DQX 2023-07-20

CROSSLEAD Penetration Peripheral Guide Wire

Applicant Asahi Intecc Co., Ltd.

K-Number K230377

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HAW 2023-07-20

ROSA ONE Brain Application

Applicant Medtech S.A.S

K-Number K231103

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