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

DSH 2017-03-24

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

Applicant Cardiac Insight, Inc.

K-Number K162503

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JAK 2017-03-24

Scan&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163297

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IOR 2017-03-24

GEN_2 and GEN_3 Mechanical Wheelchairs

Applicant Free Wheelchair Mission

K-Number K170701

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DRG 2017-03-24

FFR Link, FFR Signal Processing Module

Applicant Boston Scientific Corporation

K-Number K170204

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GWN 2017-03-23

Synapsys Ulmer Video Nystagmograph

Applicant Synapsys SA

K-Number K163558

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OHT 2017-03-23

PerfectSmooth

Applicant Shen Zhen Cosbeauty Co., Ltd.

K-Number K161428

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GWJ 2017-03-23

Eclipse with VEMP

Applicant Interacoustics A/S

K-Number K162037

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DQY 2017-03-23

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

Applicant Boston Scientific Corporation

K-Number K163314

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HBB 2017-03-23

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

Applicant Medtronic Powered Surgical Solutions

K-Number K163182

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GEX 2017-03-23

Tranberg CLS Diffusor Laser Fiber

Applicant Clinical Laserthermia Systems, AB

K-Number K163103

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FRO 2017-03-23

LOYON

Applicant Oculus Innovative Sciences

K-Number K162217

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IYN 2017-03-23

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

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

K-Number K170277

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