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

OWI 2016-03-18

NILE Alternative Fixation Spinal System

Applicant K2m, Inc.

K-Number K160208

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GEX 2016-03-18

Quanta System Surgical Laser fibers

Applicant Quanta System Spa

K-Number K160513

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NGX 2016-03-18

Slim UP ULTRA

Applicant Aime Medical, Inc.

K-Number K151722

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DIO 2016-03-18

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K153646

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JWH 2016-03-18

Optetrak Advanced Patella

Applicant Exactech, Inc.

K-Number K160484

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KDI 2016-03-18

DBB-06 Hemodialysis Delivery System

Applicant NIKKISO CO., LTD.

K-Number K152938

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IYO 2016-03-18

FibroScan 530 Compact

Applicant Echosens

K-Number K160524

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FZP 2016-03-18

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

Applicant AtriCure, Inc.

K-Number K160454

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NHJ 2016-03-17

MetaNeb 4 System

Applicant Hill-Rom Services Pte, Ltd.

K-Number K151689

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DXG 2016-03-17

LiDCOunity Monitor

Applicant Lidco, Ltd.

K-Number K152935

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MAX 2016-03-17

NuVasive® TLX Interbody System

Applicant Nu Vasive, Incorporated

K-Number K153627

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HAW 2016-03-17

ClearPoint System

Applicant Mri Interventions, Inc.

K-Number K160434

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