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

HKX 2018-12-14

Tono Vue Non-Contact Tonometer

Applicant Crystalvue Medical Corporation

K-Number K180820

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DRL 2018-12-14

UniPulse

Applicant Seaward Group

K-Number K182905

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HSB 2018-12-14

Affixus Hip Fracture Nail

Applicant Biomet, Inc.

K-Number K183162

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FTL 2018-12-14

Phasix ST Mesh with Echo 2 Positioning System

Applicant C.R. Bard, Inc.

K-Number K182008

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DQY 2018-12-14

Xcess Guiding Catheter

Applicant Curatia Medical Co.

K-Number K180797

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IRP 2018-12-14

Rapid Reboot Compression Therapy System

Applicant Rapid Reboot Recovery Products, LLC

K-Number K182668

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NKB 2018-12-13

CBT Screw Fixation System

Applicant U&I Corporation

K-Number K181824

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EBG 2018-12-13

EVOLUX CAD/CAM PMMA BLOCKS

Applicant Blue Dent Dental

K-Number K182065

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PZI 2018-12-13

StatStrip Xpress Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K182552

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MCW 2018-12-13

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Applicant Cardiovascular Systems, Inc.

K-Number K182397

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LBI 2018-12-13

neoBLUE blanket LED Phototherapy System

Applicant Natus Medical Incorporated

K-Number K182178

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LLZ 2018-12-13

HipCheck

Applicant Stryker Corp.

K-Number K182359

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