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

KDI 2020-10-08

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Applicant Bellco Srl

K-Number K193542

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HIH 2020-10-08

Schoelly Cystoscopes/Hysteroscopes and Accessories

Applicant Schoelly Fiberoptic GmbH

K-Number K201970

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LLZ 2020-10-08

IPS CaseDesigner

Applicant Nobel Biocare AB

K-Number K200810

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MAX 2020-10-08

GAIA Lumbar Interbody Fusion Device (LIFD) Family

Applicant Printerprezz

K-Number K201939

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ELW 2020-10-08

Impression Material

Applicant Zhengzhou Huaer Electro Optics Technology Co., Ltd.

K-Number K201483

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KWQ 2020-10-08

Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System

Applicant Zimmer Biomet Spine, Inc.

K-Number K202309

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PGY 2020-10-08

31HN713D

Applicant Lg Electronics.Inc

K-Number K201777

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IYN 2020-10-08

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1

Applicant Canon Medical Systems Corporation

K-Number K201972

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QDA 2020-10-08

ECG App

Applicant Apple, Inc.

K-Number K201525

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FDI 2020-10-08

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

Applicant Boston Scientific Corporation

K-Number K202478

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FRO 2020-10-08

SilverStream Gel

Applicant Enzysurge , Ltd.

K-Number K200767

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MAX 2020-10-07

Fortilink Cages with TiPlus Technology

Applicant Paradigm Spine GmbH

K-Number K201453

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