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

FAD 2024-03-22

RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

Applicant Ureteral Stent Company

K-Number K232920

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PHX 2024-03-22

Augment Off-Axis Instrument System

Applicant Fix Surgical

K-Number K233148

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BTO 2024-03-22

Pilling Tracheostomy Tubes

Applicant Teleflex Medical

K-Number K233713

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MSX 2024-03-22

Corsano CardioWatch 287-2 System

Applicant Corsano Health B.V.

K-Number K232548

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MAX 2024-03-22

aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device

Applicant Carlsmed, Inc.

K-Number K232282

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NHB 2024-03-22

SeptAlign

Applicant Spirair, Inc.

K-Number K233569

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PPN 2024-03-22

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

Applicant Shockwave Medical, Inc.

K-Number K240225

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OBP 2024-03-22

NeuroStar Advanced Therapy System (All previously cleared models)

Applicant Neuronetics, Inc.

K-Number K231926

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LNH 2024-03-22

uMR Omega

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K240540

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QYT 2024-03-22

QuickVue COVID-19 Test

Applicant Quidel Corporation

K-Number K231795

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HSB 2024-03-22

FITBONE® Transport and Lengthening System

Applicant Orthofix Srl

K-Number K232169

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QAS 2024-03-22

syngo.CT Brain Hemorrhage

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232431

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