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

LFL 2023-07-11

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K230427

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QFG 2023-07-10

Tandem Mobi Insulin Pump with Interoperable Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K223213

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NUC 2023-07-10

Play&Joy InvisiLube Lubricant Capsule

Applicant Innovemed Bio-Tech Co., Ltd.

K-Number K220646

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NKG 2023-07-10

Edge Upper Cervical System

Applicant Spinal Simplicity, LLC

K-Number K221307

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KIF 2023-07-10

Endofill

Applicant Lumendo AG

K-Number K231387

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DQK 2023-07-10

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K231091

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OWB 2023-07-10

Ziehm Vision RFD 3D

Applicant Ziehm Imaging GmbH

K-Number K231701

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PIF 2023-07-10

EnteraLoc Flow

Applicant Vonco Products

K-Number K223683

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OAS 2023-07-10

X-View 3D Pan/X-View 2D Pan

Applicant Trident S.R.L

K-Number K222666

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MUJ 2023-07-10

MOZI TPS

Applicant Manteia Technologies Co., Ltd.

K-Number K223724

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DYB 2023-07-10

CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)

Applicant Biosense Webster, Inc.

K-Number K231412

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MTD 2023-07-10

PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

Applicant Biosense Webster, Inc.

K-Number K231312

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