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

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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MAI 2019-08-22

HEALIX ADVANCE SP BIOCOMPOSITE Anchor

Applicant Medos International SARL

K-Number K191242

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JWY 2019-08-22

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

Applicant Biomerieux S.A.

K-Number K191953

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EKX 2019-08-22

Osstell Beacon

Applicant Osstell AB

K-Number K181888

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HSN 2019-08-22

INFINITY Total Ankle System, INBONE Total Ankle System

Applicant Wrightmedicaltechnologyinc

K-Number K191393

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