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

QAI 2018-09-07

Exceed Microneedling Device

Applicant Mt. Derm GmbH

K-Number K180778

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HKI 2018-09-07

RetCam 3 ; RetCam Shuttle ; RetCam Portable

Applicant Natus Medical Incorporated

K-Number K182263

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LLZ 2018-09-07

Multi Modality Viewer

Applicant Vital Images, Inc.

K-Number K182230

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JAK 2018-09-07

CTXX85

Applicant Analogic Corporation

K-Number K182147

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LZO 2018-09-07

Corin Optimized Positioning System (OPS) Femoral

Applicant Corin USA

K-Number K181061

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PLR 2018-09-06

Trabis

Applicant Coligne AG

K-Number K173893

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DZE 2018-09-06

Provata Implant System

Applicant Southern Implants (Pty), Ltd.

K-Number K180465

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LIT 2018-09-06

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

Applicant Contego Medical, LLC

K-Number K181128

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OWI 2018-09-06

Spinal Elements Cerclage System

Applicant Spinal Elements, Inc.

K-Number K180728

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QCY 2018-09-06

Sebacia Microparticles

Applicant Sebacia, Inc.

K-Number K181518

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IYO 2018-09-06

Ultrasound System SONIMAGE HS1

Applicant Konica Minolta, Inc.

K-Number K182153

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NUH 2018-09-06

Dual output digital therapy massager

Applicant Shenzhen Osto Technology Co., Ltd.

K-Number K172834

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