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

FPA 2018-06-26

IV Administration Set

Applicant B.Braun Medical, Inc.

K-Number K173361

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NKB 2018-06-26

Range (Denali and Mesa) Spinal Systems

Applicant K2m, Inc.

K-Number K181119

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LLZ 2018-06-26

DenSeeMammo

Applicant Statlife

K-Number K173574

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LRK 2018-06-26

Express 4 Sleep appliance/CPAP Sidekick appliance

Applicant Moses Appliances, LLC

K-Number K173856

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OLO 2018-06-25

Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K180690

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ODP 2018-06-25

EVOL® ha-C Cervical Interbody Fusion System

Applicant Cutting Edge Spine, LLC

K-Number K180674

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LLL 2018-06-25

QUANTA Flash HMGCR Reagents

Applicant Inova Diagnostics, Inc.

K-Number K180975

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IYN 2018-06-25

Vscan Extend

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K180995

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MAX 2018-06-25

SPIRA Open Matrix LLIF

Applicant Camber Spine Technologies, LLC

K-Number K180724

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GAP 2018-06-25

SafePath Suturing System

Applicant Safepath Medical, Inc.

K-Number K180701

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LPL 2018-06-25

Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA

Applicant Largan Medical Co., Ltd.

K-Number K181230

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ODP 2018-06-25

MONET Anterior Cervical Interbody Fusion Cage System

Applicant Ctl Medical Corporation

K-Number K172788

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