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

ITI 2023-09-05

Ki Power Tilt System

Applicant Ki Mobility, LLC

K-Number K201869

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QME 2023-09-01

FaceHeart Vitals Software Development Kit (FH vitals SDK)

Applicant Faceheart Corp.

K-Number K223622

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KPE 2023-09-01

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

Applicant Epic Medical Pte. , Ltd.

K-Number K223674

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HRS 2023-09-01

TriMed Clavicle Fixation System

Applicant TriMed, Inc.

K-Number K230805

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MAX 2023-09-01

CONDUIT™ ATP Inserters

Applicant Enztec Limited

K-Number K232014

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HRS 2023-09-01

KITE Distal Fibula Kit

Applicant Intrauma S.P.A

K-Number K230623

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LRK 2023-09-01

ApneaRX Pro

Applicant Apnea Sciences Coporation

K-Number K223901

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MOS 2023-09-01

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K232021

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OLW 2023-09-01

Brain Anesthesia Response Monitor (Bar Monitor)

Applicant Cortical Dynamics , Ltd.

K-Number K213273

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MQV 2023-09-01

Montage Flowable Settable, Resorbable Bone Paste

Applicant Orthocon, Inc.

K-Number K231270

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EHD 2023-09-01

HyperLight Portable X-ray Unit

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K-Number K232068

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EKX 2023-09-01

InnerView LC

Applicant Perimetrics, Inc.

K-Number K232657

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