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

JAK 2017-04-07

Philips iCT CT System

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K162838

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GEX 2017-04-07

MEDICAL DIODE LASER SYSTEMS

Applicant Wuhan Gigaa Optronics Technology Co., Ltd.

K-Number K160549

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OAS 2017-04-07

ORTHOPANTOMOGRAPH OP 3D

Applicant Palodex Group OY

K-Number K170813

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GEX 2017-04-07

NeuroBlate System

Applicant Monteris Medical,

K-Number K170724

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MCW 2017-04-07

Spectranetics Turbo-Elite Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K170059

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EBZ 2017-04-07

LED Curing Light

Applicant Monitex Industrial Co., Ltd.

K-Number K152192

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GCJ 2017-04-07

ZeroWire Mobile

Applicant Nds Surgical Imaging, LLC

K-Number K170598

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LOX 2017-04-07

RX Takeru Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K163372

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ODP 2017-04-07

Kepler II

Applicant Orbbo Surgical, LLC

K-Number K163265

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FRC 2017-04-07

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

Applicant Gke-GmbH

K-Number K163144

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HRS 2017-04-07

ANTHEM™ Fracture System

Applicant Globus Medical, Inc.

K-Number K163361

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OMP 2017-04-06

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

Applicant Medela AG

K-Number K170088

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