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

EIH 2018-04-24

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

Applicant Crown Porcelain Dental Technology Co., Ltd.

K-Number K180252

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OLO 2018-04-24

Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter

Applicant Smith & Nephew, Inc.

K-Number K180277

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HAW 2018-04-24

neuromate Gen III

Applicant Renishaw Mayfield Sarl

K-Number K180206

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JXI 2018-04-24

Reaxon Plus

Applicant Medovent GmbH

K-Number K180222

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JAK 2018-04-24

IMACTIS CT-Navigation system

Applicant Imactis, Sas

K-Number K162314

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JAK 2018-04-24

GSI Viewer with GSI Fat Option

Applicant GE Medical Systems SCS

K-Number K180225

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JDX 2018-04-24

XD880A Ultrasonic Osteotomy Surgical System

Applicant Morley Research Consortium

K-Number K172464

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BTR 2018-04-23

Frova Intubating Introducer

Applicant Cook Incorporated

K-Number K171917

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FRC 2018-04-23

3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader

Applicant 3M Company

K-Number K173519

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HGM 2018-04-23

AlertWatch:OB

Applicant Alertwatch, Inc.

K-Number K173715

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KWQ 2018-04-23

Cure™ Lumbar Plate System

Applicant Meditech Spine, LLC

K-Number K180090

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NUJ 2018-04-23

Reprocessed LigaSure Maryland Jaw Sealer/Divider

Applicant Stryker Sustainability Solutions

K-Number K180499

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