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

POL 2018-10-25

Solitare Platinum Revascularization Device

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K181186

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KPS 2018-10-25

Hybrid3D

Applicant Hermes Medical Solutions AB

K-Number K181468

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IYN 2018-10-25

Vivid E80, Vivid E90, Vivid E95

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K181685

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JWH 2018-10-25

Persona Revision Knee System

Applicant Zimmer, Inc.

K-Number K181947

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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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