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

OLO 2018-10-24

Spine Wave Navigated Instruments

Applicant Spine Wave, Inc.

K-Number K181596

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NEY 2018-10-24

Certus 140 2.45GHz Ablation System

Applicant Neuwave Medical, Inc.

K-Number K173756

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MQF 2018-10-24

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

Applicant Cook Incorporated

K-Number K180302

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BZK 2018-10-24

Gas Module 3

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K180788

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MAX 2018-10-24

Duo Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K182322

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NFJ 2018-10-24

Retina Workplace

Applicant Carl Zeiss Meditec, Inc.

K-Number K182318

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NAY 2018-10-24

da Vinci Xi Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K182140

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IYO 2018-10-24

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

Applicant C. R. Bard

K-Number K182281

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KNT 2018-10-24

GastroFlush

Applicant Bionix Development Corporation

K-Number K180605

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KRA 2018-10-24

VAMP Optima closed blood sampling system

Applicant Edwards Lifesciences, LLC

K-Number K180275

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BYI 2018-10-24

Monarch Airway Clearance System

Applicant Hill-Rom Holdings, Inc.

K-Number K173603

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GEI 2018-10-24

TempSure System

Applicant Cynosure, Inc.

K-Number K182365

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