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

LZG 2018-06-01

Omnipod DASH Insulin Management System

Applicant Insulet Corporation

K-Number K180045

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DQK 2018-06-01

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

Applicant Biosense Webster, Inc.

K-Number K180238

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LLZ 2018-05-31

Interventional Workspot

Applicant Philips Medical Systems Nederland B.V.

K-Number K181177

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JDQ 2018-05-31

Sternal Cable System

Applicant A & E Medical Corporation

K-Number K180582

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IYN 2018-05-31

ACUSON SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181098

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HRX 2018-05-31

Single Use Arthroscopic Electrode (with Pencil)

Applicant Modern Medical Equipment Manufacturing Limited

K-Number K170703

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DSP 2018-05-31

CARDIOSAVE Intra-Aortic Balloon Pump

Applicant Datascope Corp.

K-Number K181122

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NAY 2018-05-31

EndoWrist 5mm Thoracic Grasper

Applicant Intuitive Surgical, Inc.

K-Number K173415

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NAY 2018-05-31

da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

Applicant Intuitive Surgical, Inc.

K-Number K173906

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KOI 2018-05-31

ToFscan

Applicant Idmed

K-Number K172690

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MBI 2018-05-31

AEVUMED PHANTOM Suture Anchors

Applicant Aevumed, Inc.

K-Number K180464

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PHM 2018-05-31

ATEC Universal Spacer System

Applicant Alphatec Spine, Inc.

K-Number K180480

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