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

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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FJL 2024-05-07

KARL STORZ Monopolar Resectoscopes with HF Cable

Applicant Karl Storz SE & CO. KG

K-Number K232486

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PHL 2024-05-07

Medical HAL Lower Limb Type (HAL-ML)

Applicant Cyberdyne, Inc.

K-Number K233695

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NKB 2024-05-06

JAZZ Spinal System

Applicant Implanet

K-Number K240392

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HRX 2024-05-06

Vertos mild Device Kit (MDK-0002)

Applicant Vertos Medical, Inc.

K-Number K233800

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LLZ 2024-05-06

MIM – Dose Analysis

Applicant Mim Software, Inc.

K-Number K232514

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KNT 2024-05-06

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

Applicant Boehringer Laboratories, LLC

K-Number K234033

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NKB 2024-05-06

Salvo® Spine System

Applicant Spine Wave, Inc.

K-Number K240685

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