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

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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GCJ 2024-08-28

da Vinci Handheld Camera

Applicant Intuitive Surgical Operations, Inc.

K-Number K241913

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OCL 2024-08-27

Isolator Synergy EnCapture Ablation System (EMH)

Applicant AtriCure, Inc.

K-Number K234151

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GZJ 2024-08-27

TENSWave

Applicant Zynex Medical Officer

K-Number K241228

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ITI 2024-08-27

Electric wheelchair (S7018)

Applicant Guangdong Prestige Technology Company Limited

K-Number K240270

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DXT 2024-08-27

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

Applicant Nemoto Kyorindo Co., Ltd.

K-Number K242212

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