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

IPF 2016-04-14

Chattanooga Revolution Wireless

Applicant Djo, LLC

K-Number K153696

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MAV 2016-04-13

Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

Applicant Medtronic, Inc.

K-Number K153038

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GEI 2016-04-13

Neptune E-SEP Smoke Evacuation Pencil

Applicant Stryker Corporation

K-Number K160693

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MAX 2016-04-13

NuVasive CoRoent Thoracolumbar System

Applicant Nu Vasive, Incorporated

K-Number K153419

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GAD 2016-04-13

JRP Wound Spreader

Applicant J.R. Parker, LLC

K-Number K152538

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GEH 2016-04-13

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

Applicant C2 Therapeutics, Inc.

K-Number K152329

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MAX 2016-04-13

SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer

Applicant Globus Medical, Inc.

K-Number K143578

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NKB 2016-04-13

Diplomat® Spinal System

Applicant Signus Medizintechnik GmbH

K-Number K151704

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EMA 2016-04-13

Ketac Universal Aplicap

Applicant 3M Deutschland GmbH

K-Number K153174

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MNS 2016-04-13

Juno VPAP ST-A

Applicant Resmed, Ltd.

K-Number K153061

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FYA 2016-04-13

Aero Chrome* Breathable Performance Surgical Gown

Applicant Halyard Health, Inc.

K-Number K153255

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JAQ 2016-04-13

Varian Sterilization Boxes

Applicant Varian Medical Systems, Inc.

K-Number K160021

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