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

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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JIN 2020-09-09

KetoSens BT Blood B-Ketone Monitoring System

Applicant I-Sens, Inc.

K-Number K201551

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LLZ 2020-09-09

AcroDTI Visualizer

Applicant Acroviz, Inc.

K-Number K201948

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HRS 2020-09-09

DePuy Synthes Variable Angle Locking Patella Plating System

Applicant Synthes (USA) Products, LLC

K-Number K201578

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CHW 2020-09-09

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

Applicant Biosystems S.A.

K-Number K192730

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KGO 2020-09-09

SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K201829

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