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

LNH 2022-07-28

Swoop Portable MR Imaging System

Applicant Hyperfine, Inc.

K-Number K221923

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NKB 2022-07-28

INERTIA CONNEXX Modular Pedicle Screw System

Applicant Nexxt Spine, LLC

K-Number K221905

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OWB 2022-07-28

Trinias

Applicant Shimadzu Corporation Medical Systems Division

K-Number K221922

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OWB 2022-07-28

TRON

Applicant Xoran Technologies, LLC

K-Number K221230

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FDX 2022-07-28

Single Use Cytology Brush

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K220063

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QIH 2022-07-28

cvi42 Auto Imaging Software Application

Applicant Circle Cardiovascular Imaging, Inc.

K-Number K213998

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KNT 2022-07-28

Gastrointestinal Boundary Identifier (GIBI HD)

Applicant Reshape Lifesciences

K-Number K221898

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NKB 2022-07-28

OsteoCentric Spine MIS Pedicle Fastener System

Applicant OsteoCentric Technologies

K-Number K221332

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QBD 2022-07-28

MagXtract Collection Tube

Applicant Magbio Genomics, Inc.

K-Number K212113

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PCI 2022-07-28

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

Applicant Becton, Dickinson and Company

K-Number K214122

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EOQ 2022-07-28

EXALT Model B Single-Use Bronchoscope

Applicant Boston Scientific Corporation

K-Number K222014

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LFL 2022-07-28

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K-Number K221235

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