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

LXM 2019-12-21

Spinalytics

Applicant Optima Health Solutions International Corp.

K-Number K192629

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LZO 2019-12-21

Acetabular Bone Screws (for MobileLink Acetabular Cup System)

Applicant Waldemar Link GmbH & Co. KG

K-Number K192559

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EIH 2019-12-20

Non-Sterile Zirconia Block

Applicant Fine Advanced Compound Co., Ltd.

K-Number K190112

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MHX 2019-12-20

Carescape One

Applicant GE Healthcare

K-Number K190008

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FET 2019-12-20

Telepack +

Applicant Karl Storz Endoscopy America, Inc.

K-Number K193235

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MQB 2019-12-20

Nexus DR Digital X-Ray Imaging System (with vSharp)

Applicant Varex Imaging Corporation

K-Number K193238

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FRO 2019-12-20

IODOFLEX

Applicant Smith & Nephew Medical, Ltd.

K-Number K190756

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NXC 2019-12-20

Clear-Aligners

Applicant Cdb Corporation

K-Number K191823

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GEX 2019-12-20

Litho Evo

Applicant Quanta System Spa

K-Number K192990

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GEI 2019-12-20

WEREWOLF COBLATION System, COBLATION HALO Wand

Applicant ArthroCare Corporation

K-Number K192027

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GEH 2019-12-20

IceSense 3, ProSense, MultiSense

Applicant IceCure Medical , Ltd.

K-Number K183213

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KPR 2019-12-20

DRX-Evolution with Carestream Digital Tomosynthesis

Applicant Carestream Health, Inc.

K-Number K191879

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