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

OWQ 2023-06-06

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Applicant Vein 360, LLC

K-Number K230584

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GEX 2023-06-06

Diode laser therapy device

Applicant Triangel Rsd Limited

K-Number K212734

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GEX 2023-06-06

Diode laser therapy device

Applicant Beijing Star New Tech Co., Ltd.

K-Number K212733

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MWI 2023-06-06

ARC Intensive Care Information System (ARC System)

Applicant Ordinatrum Solutions

K-Number K220117

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GEI 2023-06-05

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230498

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LGZ 2023-06-05

Fluido Compact Blood and Fluid Warming System

Applicant The Surgical Company International B.V.

K-Number K211618

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QSE 2023-06-05

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

Applicant Roche Diagnostics

K-Number K231348

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PHX 2023-06-05

FX V135(TM) Shoulder Prosthesis

Applicant Fx Shoulder USA, Inc.

K-Number K223801

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GCJ 2023-06-05

HandX Self-Righting Needle Holder

Applicant Human Xtensions , Ltd.

K-Number K223718

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DHA 2023-06-05

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

Applicant Abbott Laboratories

K-Number K230937

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IOR 2023-06-05

Zhenjiang Assure Mechanical Wheelchair,model:K1

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K231320

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LZA 2023-06-05

APOLLO ADVANTAGE Nitrile Examination Gloves

Applicant Dell Corning Corporation

K-Number K230633

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