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

QDJ 2020-08-17

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Applicant 23AndMe, Inc.

K-Number K193492

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OWN 2020-08-17

HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

Applicant Karl Storz-Endoscopy-America, Inc.

K-Number K201399

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LLZ 2020-08-17

3D Auto LAA

Applicant Philips Health Care

K-Number K201352

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JAQ 2020-08-17

Universal Cylinder Applicator Family

Applicant Varian Medical Systems, Inc.

K-Number K193240

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LYC 2020-08-17

Cytrans Granules

Applicant GC America, Inc.

K-Number K192597

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NHA 2020-08-16

Sirona Dental CAD/CAM System with CEREC Chairside Software

Applicant Dentsply Sirona

K-Number K193408

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DYH 2020-08-14

Orthocem, Ortho Bite

Applicant Dentscare Ltda

K-Number K192682

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LPH 2020-08-14

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K191708

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DYH 2020-08-14

BracePaste Band and Build LC

Applicant American Orthodontics

K-Number K202276

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EBF 2020-08-14

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

Applicant Nobio , Ltd.

K-Number K201010

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MQV 2020-08-14

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft

Applicant SurGenTec, LLC

K-Number K200064

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LLZ 2020-08-14

TOMTEC-ARENA

Applicant Tomtec Imaging Systems GmbH

K-Number K201632

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