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

PGW 2017-02-09

Scopis Hybrid Navigation System EM

Applicant Scopis GmbH

K-Number K161491

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JAK 2017-02-09

syngo. CT Single Source Dual Energy (twin beam)

Applicant Siemens Medical Solutions USA, Inc., Ultrasound DI

K-Number K163289

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MQB 2017-02-09

pixium 4343RCE

Applicant Philips Medical Systems Dmc GmbH

K-Number K170113

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MAX 2017-02-09

Atlas Spine Expandable Interbody System

Applicant Atlas Spine, Inc.

K-Number K162918

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EOQ 2017-02-09

PeriFLEX

Applicant Spiration, Inc.

K-Number K162611

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JKA 2017-02-09

PIVO

Applicant Velano Vascular

K-Number K163508

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KNT 2017-02-09

Low Profile Balloon Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K161413

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OCC 2017-02-09

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant Cepheid

K-Number K162331

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JAK 2017-02-09

syngo.CT Extended Functionality

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163341

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HWC 2017-02-09

RASL Repair Kit

Applicant Radicle Orthopaedics, Inc.

K-Number K161334

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LSL 2017-02-09

cobas® CT/NG v2.0 Test

Applicant Roche Molecular Systems, Inc.

K-Number K163184

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HRS 2017-02-09

APTUS® Coronoid 2.0

Applicant Medartis AG

K-Number K161861

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