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

MNU 2024-08-28

OSSIOfiber® Compression Staple

Applicant OSSIO , Ltd.

K-Number K241932

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LIP 2024-08-28

VITROS Immunodiagnostic Products Syphilis Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K241534

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DXE 2024-08-28

Fogarty Thru-Lumen Embolectomy Catheter

Applicant Edwards Lifesciences, LLC

K-Number K240078

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EIH 2024-08-28

Cercon® yo ML

Applicant Dentsply Sirona

K-Number K241557

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SCS 2024-08-28

Chronos®

Applicant Germitec

K-Number DEN230067

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HRS 2024-08-28

REDEMPTION Charcot Plating System

Applicant Vilex, LLC

K-Number K233816

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CBK 2024-08-28

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask

Applicant Sleepnet Corporation

K-Number K241943

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QGL 2024-08-28

BT-1000

Applicant Bistos Co., Ltd.

K-Number K232991

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LZA 2024-08-28

GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

Applicant Genabio Diagnostics, Inc.

K-Number K240545

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KIF 2024-08-28

Vista BC Putty

Applicant Inter-Med, Inc.

K-Number K241457

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DQA 2024-08-28

OxiWear

Applicant Oxiwear, Inc.

K-Number K233827

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FMK 2024-08-28

Safety Lancet

Applicant Ningbo Medsun Medical Co., Ltd.

K-Number K242316

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