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

LQR 2017-12-12

Wittich Nitinol Stone Basket

Applicant Cook Incorporated

K-Number K170898

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FDF 2017-12-12

Pure-Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K173392

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IYN 2017-12-12

Xario 200 Diagnostic Ultrasound System V6.0

Applicant Toshibamedical Systems Corporation

K-Number K172276

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FCG 2017-12-12

Sterile Endoscope Biopsy Sampling Needle

Applicant Changzhou Detain Medical Devices Co., Ltd.

K-Number K171956

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DXT 2017-12-12

Disposable High Pressure Syringe

Applicant Union Medical Shenzhen Co., Ltd.

K-Number K170279

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FMI 2017-12-12

DropSafe Safety Pen Needle

Applicant Htl-Strefa S.A

K-Number K170988

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LRC 2017-12-12

MESIRE - Balloon Sinus Dilatation System

Applicant M/S. Meril Life Sciences Private Limited

K-Number K172737

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FRC 2017-12-12

SporView Rapid Read Biological Indicator

Applicant Crosstex/Spsmedical, A Division of Cantel Medical

K-Number K172432

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JDR 2017-12-11

SNIPER STAPLE SYSTEM, NON-STERILE

Applicant Trilliant Surgical

K-Number K172405

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KPR 2017-12-11

Optima XR646 HD

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K173612

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MSS 2017-12-11

Crystalsert Lens Delivery System

Applicant Bausch & Lomb, Inc.

K-Number K173480

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NKB 2017-12-11

CorticaLINK Spinal Fusion Platform

Applicant Linkspine, Inc.

K-Number K173484

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