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

BZC 2019-08-23

Vyntus/SentrySuite Product Line

Applicant Vyaire Medical

K-Number K183567

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PON 2019-08-23

CrossBay Cervical Dilator Catheter System

Applicant Crossbay Medical

K-Number K190813

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GCJ 2019-08-23

LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head

Applicant Smith and Nephew, Inc.

K-Number K191177

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FWP 2019-08-23

Customized Contour Implant

Applicant Implantech Associates, Inc.

K-Number K191130

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DQK 2019-08-23

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

Applicant iRhythm Technologies, Inc.

K-Number K190593

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HRS 2019-08-23

VariAx 2 System, VariAx 2 Mini Fragment System

Applicant Stryker GmbH

K-Number K191412

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OVD 2019-08-23

Rampart One Lumbar Interbody Fusion System

Applicant Spineology, Inc.

K-Number K192047

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LLZ 2019-08-23

Efficient Care 3D Planning

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

K-Number K183544

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DQO 2019-08-22

Bendit2.7 Steerable Microcatheter

Applicant Bend IT Technologies, Ltd.

K-Number K190126

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HRS 2019-08-22

NCB Polyaxial Locking Plate System

Applicant Zimmer GmbH

K-Number K192021

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JWH 2019-08-22

Triathlon Total Knee System-Additional Components

Applicant Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)

K-Number K190402

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DQA 2019-08-22

BB-613WP

Applicant Biobeat Technologies , Ltd.

K-Number K190792

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