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

FLL 2018-06-07

Digital Thermometer

Applicant Fudakang Industrial Co., Ltd.

K-Number K172121

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HSX 2018-06-07

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K180612

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OAS 2018-06-07

Orthopantomograph OP 3D

Applicant Palodex Group OY

K-Number K180947

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OHS 2018-06-07

ELEVARE, PERFECTIO 4

Applicant Omm Imports D/B/A Zero Gravity

K-Number K172909

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BSP 2018-06-07

Pakter Curved Needle Set

Applicant Cook Incorporated

K-Number K173155

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LHI 2018-06-07

Guarded Luer Connector

Applicant International Medical Industries, Inc.

K-Number K173577

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EBF 2018-06-07

Tetric CAD

Applicant Ivoclar Vivadent, AG

K-Number K173573

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PMC 2018-06-07

Paxman Scalp Cooler

Applicant Paxman Coolers Limited

K-Number K173032

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HKY 2018-06-07

AT 030

Applicant Carl Zeiss Meditec, AG

K-Number K180839

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PLP 2018-06-07

FOCAL ONE

Applicant Edap Technomed, Inc.

K-Number K172721

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LLZ 2018-06-07

QLAB Advanced Quantification Software

Applicant Philips Ultrasound, Inc.

K-Number K181264

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ONN 2018-06-07

VERASENSE for Zimmer Biomet Persona

Applicant Orthosensor, Inc.

K-Number K180459

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