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

GEI 2020-03-06

PhotonBlade with Smoke Evacuation

Applicant Invuity, Inc.

K-Number K191583

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GCJ 2020-03-06

1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality

Applicant Stryker

K-Number K200310

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KCT 2020-03-06

Avinent Surgical Tray

Applicant Avinent Implant System S.L.U.

K-Number K191566

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LLZ 2020-03-05

Kinepict Medical Imaging Tool version v2.2

Applicant Kinepict Health, Ltd.

K-Number K190993

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MBI 2020-03-05

ALLthread PEEK Suture Anchor

Applicant Biomet, Inc.

K-Number K193402

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MJH 2020-03-05

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

Applicant Ssi Diagnostica A/S

K-Number K191184

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QDQ 2020-03-05

Transpara

Applicant Screenpoint Medical B.V.

K-Number K193229

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ONF 2020-03-05

Lucent : IPL

Applicant Luvo Medical Technologies, Inc.

K-Number K193072

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PKL 2020-03-05

Instinct Plus Endoscopic Clipping Device

Applicant Cook Endoscopy

K-Number K192697

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FMF 2020-03-05

Omnifix Low Dead Space Luer Lock Syringe

Applicant B.Braun Medical, Inc.

K-Number K193101

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NDN 2020-03-05

V-STRUT Vertebral Implant

Applicant Hyprevention Sas

K-Number K191709

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NHA 2020-03-05

ATLANTIS Abutment for MIS Conical Connection Implants

Applicant Dentsply Sirona

K-Number K193529

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