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

NXC 2020-09-10

Straight T Clear Dental Aligner

Applicant Straight T, Inc.

K-Number K201450

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IOR 2020-09-10

RGK Daily Range Wheelchairs

Applicant Rgk Wheelchairs, Ltd.

K-Number K200135

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MAX 2020-09-10

X-Pac Expandable Lumbar Cage System

Applicant Expanding Innovations, Inc.

K-Number K201145

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OLO 2020-09-10

Navigation Module of the Momentum System

Applicant Ulrich Medical USA

K-Number K200845

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PDU 2020-09-10

Tigereye CTO-Crossing Catheter

Applicant Avinger, Inc.

K-Number K201330

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HJK 2020-09-10

RxSight Contact Lens

Applicant Rxsight, Inc.

K-Number K201909

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PKT 2020-09-10

Diode Laser Body Sculpture System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K201731

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GEI 2020-09-10

SubNovii Advanced Plasma Technology

Applicant Cartessa Aesthetics

K-Number K201738

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KPR 2020-09-10

DIAMOND-5A/6A/8A

Applicant DRGEM Corporation

K-Number K202156

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GAT 2020-09-10

HS Fiber

Applicant Riverpoint Medical, LLC

K-Number K202242

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LYZ 2020-09-10

Disposable Vinyl Glove

Applicant Best Care Trading Co., Ltd.

K-Number K202008

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JEY 2020-09-10

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

Applicant Synthes (USA) Products, LLC

K-Number K201944

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