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

GEI 2024-05-08

FLOW 90? Wand

Applicant ArthroCare Corporation

K-Number K240964

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GEX 2024-05-08

UltraClear Laser System (N/A)

Applicant Acclaro Corporation

K-Number K233803

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MQG 2024-05-07

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

Applicant Wuhan Huchuang Union Technology Co., Ltd.

K-Number K232493

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GAG 2024-05-07

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

Applicant Lexington Medical, Inc.

K-Number K234039

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QKB 2024-05-07

DeepContour (V1.0)

Applicant Wisdom Technologies., Inc.

K-Number K232928

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PSY 2024-05-07

HALO AP Dx

Applicant Indica Labs, Inc.

K-Number K232833

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DSA 2024-05-07

LIFEPAK® ECG Cables

Applicant Stryker Physio-Control

K-Number K240377

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NHA 2024-05-07

CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System

Applicant Dentsply Sirona

K-Number K234018

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PPN 2024-05-07

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

Applicant Shockwave Medical, Inc.

K-Number K240954

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PAY 2024-05-07

Geneo X Elite

Applicant Pollogen, Ltd.

K-Number K233766

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MWJ 2024-05-07

ASSURE Wearable ECG

Applicant Kestra Medical Technologies, Inc.

K-Number K233864

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JAI 2024-05-07

Eve Patient Positioner System

Applicant Leo Cancer Care

K-Number K231612

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