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

MQV 2019-08-09

Morpheus-C

Applicant Biogennix, LLC

K-Number K190371

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IYN 2019-08-09

Versana Active

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K191798

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DQY 2019-08-09

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter

Applicant Vascular Solutions, LLC

K-Number K191560

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PQK 2019-08-09

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

Applicant Avenu Medical

K-Number K191114

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KDI 2019-08-09

NxStage Cartridge Express with Speedswap

Applicant Nxstage Medical, Inc.

K-Number K183158

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IYN 2019-08-09

Versana Balance

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K191792

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HBE 2019-08-09

ELAN 4 Tools

Applicant Aesculap, Inc.

K-Number K183203

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GEX 2019-08-09

SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories)

Applicant Olympus Surgical Technologies America

K-Number K183647

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IYN 2019-08-09

ARIETTA 750

Applicant Hitachi Healthcare Americas

K-Number K191233

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JWH 2019-08-08

iTotal Identity Cruciate Retaining Knee Replacement System

Applicant Conformis, Inc.

K-Number K190562

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LZO 2019-08-08

Conformity Stem

Applicant United Orthopedic Corporation

K-Number K183312

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NKB 2019-08-08

ARx Spinal System

Applicant Life Spine, Inc.

K-Number K191575

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