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

KCT 2018-01-22

Kit Boxes and Kit Plates

Applicant Nobel Biocare AB

K-Number K163600

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NKG 2018-01-22

Centurion POCT System

Applicant Orthofix, Inc.

K-Number K180025

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DQX 2018-01-22

Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile

Applicant Scientia Vascular, LLC

K-Number K173235

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LQP 2018-01-22

CAMPYLOBACTER CHEK

Applicant Techlab, Inc.

K-Number K173219

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DPS 2018-01-22

CONTEC Electrocardiograph

Applicant Contec Medical Systems Co.,Ltd

K-Number K171360

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LNH 2018-01-22

3D APT

Applicant Philips Medical Systems Nederland B.V.

K-Number K172920

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FRC 2018-01-22

3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader

Applicant 3M Company

K-Number K173584

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OIF 2018-01-19

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Applicant Kronus, Inc.

K-Number K171731

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MEH 2018-01-19

LINK® BiMobile(TM) Dual Mobility System

Applicant Waldemar Link GmbH & Co. KG

K-Number K171273

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MAI 2018-01-19

Fiji Anchor

Applicant Sportwelding GmbH

K-Number K171228

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NQW 2018-01-19

Choice Spine Laminoplasty Fixation System

Applicant Choicespine, LP

K-Number K173215

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DZE 2018-01-19

Straumann Dental Implant System

Applicant Straumann USA, LLC

K-Number K171784

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