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

CAF 2019-06-07

Hailie Sensor

Applicant Adherium (Nz), Ltd.

K-Number K182573

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BZG 2019-06-06

ComPAS2 (Computerized Pulmonary Analysis System)

Applicant Morgan Scientific, Inc.

K-Number K190568

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HRS 2019-06-06

PROSTEP TBC Implant System

Applicant Wrightmedicaltechnologyinc

K-Number K183620

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OVD 2019-06-06

Idys ALIF TiVac

Applicant Clariance, Sas

K-Number K191263

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LON 2019-06-06

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

Applicant bioMerieux, Inc.

K-Number K190616

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HIH 2019-06-06

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K-Number K191335

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ODP 2019-06-06

RIGEL PEEK Anterior Cervical Interbody Fusion System

Applicant MiRus, LLC

K-Number K190618

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HIH 2019-06-06

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

Applicant Uvision360, Inc.

K-Number K190827

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FDF 2019-06-06

Pure Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K191220

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GCJ 2019-06-06

da Vinci Handheld Camera

Applicant Intuitive Surgical, Inc.

K-Number K191043

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KWT 2019-06-05

Signature ONE System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K190595

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EHD 2019-06-05

MINE

Applicant Rht Co., Ltd.

K-Number K180671

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