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

JAA 2018-04-05

DR 800 with MUSICA Dynamic

Applicant Agfa Healthcare N.V.

K-Number K180589

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DQY 2018-04-05

Wedge Microcatheter

Applicant MicroVention, Inc.

K-Number K172014

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DZE 2018-04-05

SIC invent Dental Implant Systems

Applicant Sic Invent AG

K-Number K173207

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HKI 2018-04-05

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

Applicant Optomed OY

K-Number K180378

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MCW 2018-04-05

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K180694

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LLZ 2018-04-04

Scenium VE20 Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173597

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IWB 2018-04-04

GammaPod

Applicant Xcision Medical Systems, LLC

K-Number K180571

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MBI 2018-04-04

ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor

Applicant Stryker

K-Number K173074

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HGX 2018-04-04

The Pump by Babyation

Applicant Babyation, LLC

K-Number K173699

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EHD 2018-04-04

MobileX Portable X-ray System

Applicant Denterprise International, Inc.

K-Number K180561

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LNH 2018-04-04

Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4

Applicant Philips Medical Systems Nederland B.V.

K-Number K173079

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FRO 2018-04-04

Algidex Ag Silver Alginate Wound Dressing

Applicant Deroyal Industries, Inc.

K-Number K173072

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