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

EIA 2020-02-05

Infinity / Infinity Cross Flex Dental Systems

Applicant Olsen Industria E Comercio S.A.

K-Number K180935

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EBG 2020-02-05

DENTCA Crown and Bridge

Applicant Dentca, Inc.

K-Number K192806

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LZF 2020-02-05

OptiScanner® 5000 Glucose Monitoring System

Applicant Optiscan Biomedical Corporation

K-Number K192785

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KWQ 2020-02-05

SpineNet SSP System

Applicant Spinenet, LLC

K-Number K200170

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HIH 2020-02-05

Endosee System

Applicant CooperSurgical, Inc.

K-Number K200038

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NKB 2020-02-05

PERLA® TL posterior osteosynthesis system

Applicant Spineart

K-Number K193396

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JKA 2020-02-04

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

Applicant Kurin, Inc.

K-Number K191832

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IWB 2020-02-04

Akesis Galaxy RTx

Applicant Akesis, Inc.

K-Number K200050

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DZE 2020-02-04

s-Clean SQ-SL Implant System Regular

Applicant Dentis Co., Ltd.

K-Number K192688

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MEH 2020-02-04

Summit DuoFix HA Coating

Applicant DePuy Orthopaedics, Inc.

K-Number K193398

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LNH 2020-02-04

Motion Correction System

Applicant Kineticor, Inc.

K-Number K193324

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KRD 2020-02-04

The Caterpillar and Caterpillar Micro Arterial Embolization Devices

Applicant C.R. Bard, Inc.

K-Number K191532

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