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

FGB 2024-08-16

Avicenna Roboflex

Applicant Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi

K-Number K233700

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QIH 2024-08-16

qCT LN Quant

Applicant Qure.Ai Technologies

K-Number K240740

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FGB 2024-08-16

Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance

Applicant Ambu A/S

K-Number K242108

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MXK 2024-08-16

BOSS™

Applicant Intelon Optics, Inc.

K-Number K223700

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NPM 2024-08-16

Xenograft Bovine Bone Particulate

Applicant Collagen Solutions, LLC

K-Number K240133

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MQF 2024-08-16

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K-Number K240307

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JEY 2024-08-16

KLS Martin Oral-Max Implants MR Conditional (bundled)

Applicant KLS-Martin L.P.

K-Number K241314

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CAC 2024-08-16

XTRA Collection sets; XTRA Sequestration set X

Applicant Sorin Group Italia S.R.L.

K-Number K241236

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HIH 2024-08-16

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K240978

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NBW 2024-08-16

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K222126

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QRK 2024-08-15

MICROLET®NEXT Lancet

Applicant Ascensia Diabetes Care U.S., Inc.

K-Number K241810

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ITX 2024-08-15

UltraDrape UGPIV Barrier and Securement (34-15)

Applicant Parker Laboratories, Inc.

K-Number K233965

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