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

NKB 2023-07-06

VERTICALE® Triangular Fixation System

Applicant Silony Medical GmbH

K-Number K223806

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BWF 2023-07-05

LungTrainer (MD2 & MD3)

Applicant Lung Trainers, LLC

K-Number K221058

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GAR 2023-07-05

Tissue Approximation System (TAS)

Applicant Tas Medical, Inc.

K-Number K220980

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ODP 2023-07-05

Integral Titanium Cervical Interbody

Applicant Nvision Biomedical Technologies, Inc.

K-Number K222015

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INI 2023-07-05

Electric Scooter (Model: M2020)

Applicant Guangdong Prestige Technology Co., Ltd.

K-Number K230001

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GCJ 2023-07-05

Universal Seal (5-12 mm)

Applicant Intuitive Surgical, Inc.

K-Number K231358

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LON 2023-07-05

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

Applicant bioMerieux, Inc.

K-Number K230864

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MAI 2023-07-05

Rotium Bioresorbable Wick

Applicant Nanofiber Solutions, LLC

K-Number K231641

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KRA 2023-07-05

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm

Applicant Ablative Solutions, Inc.

K-Number K231279

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LZA 2023-07-04

MemorialTM Gloves

Applicant Us Glove Supply

K-Number K231740

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OHT 2023-07-03

IVYLASER Handhold Hair Removal Machine

Applicant Ivylaser (Beijing) Technology Co.,Ltd

K-Number K230025

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OLP 2023-07-03

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

Applicant Light Tree Ventures Europe B.V.

K-Number K230720

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