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

DQA 2023-11-30

Wrist Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K230587

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GEX 2023-11-30

Q-Switched Nd:Yag laser

Applicant Hebei Zhemai Technology Co., Ltd.

K-Number K232716

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JAK 2023-11-30

syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232155

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IYN 2023-11-30

EPIQ Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K233545

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FAN 2023-11-30

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Applicant Surgease Innovations Limited

K-Number K232262

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GEX 2023-11-30

Diode laser therapy device

Applicant Hebei Zhemai Technology Co., Ltd.

K-Number K232709

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MBI 2023-11-30

IDEAL Ziploop

Applicant Riverpoint Medical

K-Number K233552

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MAX 2023-11-30

TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K232611

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LJS 2023-11-30

L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters

Applicant Argon Medical Devices

K-Number K230669

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MNR 2023-11-30

Somfit

Applicant Compumedics Limited

K-Number K231546

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QJP 2023-11-30

Radical the Dude 7F Guide Catheter

Applicant Maduro Medical, Inc.

K-Number K231393

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FMF 2023-11-30

NavaClick Injection System

Applicant Lineage Biomedical, Inc.

K-Number K231877

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