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

QOK 2021-04-01

Gili Pro BioSensor (also known as Gili BioSensor System)

Applicant Continuse Biometrics , Ltd.

K-Number DEN200038

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LZO 2021-04-01

KOSMO Femoral Stem

Applicant B-One Ortho, Corp.

K-Number K202768

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DRY 2021-04-01

B-Capta

Applicant Livanova Deutschland, GmbH

K-Number K202154

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LYL 2021-04-01

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Applicant Vuesonic, LLC

K-Number K210300

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IYN 2021-04-01

ACUSON Redwood Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210743

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OLO 2021-04-01

TSolution One Total Knee Application

Applicant THINK Surgical, Inc.

K-Number K210668

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IZL 2021-04-01

Nanox Cart X-ray System

Applicant Nano-X Imaging , Ltd.

K-Number K203782

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DTZ 2021-04-01

AMG PMP Pediatric

Applicant Eurosets S.R.L

K-Number K202206

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LPL 2021-04-01

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

Applicant Largan Medical Co., Ltd.

K-Number K202129

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LLZ 2021-04-01

Simpleware ScanIP Medical

Applicant Synopsys (Northern Europe) , Ltd.

K-Number K203195

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FDT 2021-04-01

Pentax Medical Video Duodenoscope ED32-i10

Applicant Pentax of America, Inc.

K-Number K202365

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KNW 2021-03-31

Avitus(r) Bone Harvester

Applicant Avitus Orthopaedics, Inc.

K-Number K210631

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