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

MPN 2024-03-16

Meriglu Topical Skin Adhesive

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K230981

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FRC 2024-03-15

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)

Applicant 3M Company

K-Number K233814

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POK 2024-03-15

CINA-ASPECTS

Applicant Avicenna.Ai

K-Number K233342

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DQY 2024-03-15

APRO 55 Catheter

Applicant Alembic, LLC

K-Number K234115

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QUH 2024-03-15

Concha Sol Hearing Aids (CL-1001)

Applicant Concha Labs

K-Number K233747

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LON 2024-03-15

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)

Applicant Becton, Dickinson and Company

K-Number K233986

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FOZ 2024-03-15

Nouvo Safety Set

Applicant Poly Medicure Limited

K-Number K232234

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GEX 2024-03-15

PICOANDY (Q-Switched Nd:YAG Laser)

Applicant Wontech Co., Ltd.

K-Number K234104

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QEW 2024-03-15

Aventus Thrombectomy System (IM-2001/IM-0002)

Applicant Inquis Medical

K-Number K240117

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OWB 2024-03-15

CIARTIC Move (VB10)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233748

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PMS 2024-03-15

ivWatch® Model 400

Applicant Ivwatch, LLC

K-Number K233881

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EBF 2024-03-15

Light Cure Composite

Applicant Sincera Technology (Changchun) Co., Ltd.

K-Number K240112

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