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

GDW 2020-10-28

Tri-Staple 2.0 Reloads

Applicant Covidien

K-Number K202864

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POV 2020-10-28

LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

Applicant Bonraybio Co., Ltd.

K-Number K202089

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MBF 2020-10-28

Comprehensive Shoulder System

Applicant Biomet Manufacturing Corp

K-Number K193038

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NKB 2020-10-28

LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K200790

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GWF 2020-10-28

NIM Vital, Nerve Integrity Monitor

Applicant Medtronic Xomed, Inc.

K-Number K200759

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MQC 2020-10-28

Thermoforming Sheet Materials

Applicant Erkodent Erich Kopp GmbH

K-Number K200125

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EBF 2020-10-27

Bright Low Flow

Applicant Genoss Co., Ltd.

K-Number K200156

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NHA 2020-10-27

TIB Abutment System

Applicant Southern Implants (Pty), Ltd.

K-Number K193084

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EBG 2020-10-27

FREEPRINT temp

Applicant Detax GmbH & Co. KG

K-Number K200273

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SBF 2020-10-27

NextAR TKA Platform

Applicant Medacta International S.A.

K-Number K202152

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LLZ 2020-10-27

OrthoNext Platform System

Applicant Orthofix Srl

K-Number K202519

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OAS 2020-10-27

Dental Computed Tomography X-Ray System, Green X

Applicant VATECH Co., Ltd.

K-Number K201627

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