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

HIF 2020-07-29

PNEUMOCLEAR

Applicant W.O.M. World of Medicine GmbH

K-Number K201361

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JEY 2020-07-29

BoniPlus Dental G-Mesh System

Applicant Montjade Engineering Co., Ltd.

K-Number K182759

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PFO 2020-07-29

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

Applicant Med-El Elektromedizinische Geraete GmbH

K-Number K200504

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DSH 2020-07-29

Bioflux Software II

Applicant Biotricity

K-Number K201040

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KWQ 2020-07-28

AccelFix Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K-Number K192481

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FPA 2020-07-28

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)

Applicant Jiangsu Kangbao Medical Equipment Co., Ltd.

K-Number K192681

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LIT 2020-07-28

Jade

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K201794

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PJD 2020-07-28

Quantisal Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K200801

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PLV 2020-07-28

Neocis Guidance System (NGS) with Patient Splints

Applicant Neocis, Inc.

K-Number K200805

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KRA 2020-07-28

TRUSELECT Microcatheter

Applicant Boston Scientific Corporation

K-Number K201792

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GCJ 2020-07-28

Connected OR Hub with Voice Control, Connected OR Hub with Device Control

Applicant Stryker

K-Number K201434

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LNH 2020-07-28

SyMRI

Applicant Syntheticmr AB

K-Number K201616

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