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

KIF 2023-07-28

Bright MTA Sealer Plus

Applicant Genoss Co., Ltd.

K-Number K231480

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QAI 2023-07-28

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

Applicant Esthetic Medical, Inc.

K-Number K231073

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EOB 2023-07-28

PatCom Distal Chip Endoscope

Applicant H&A Mui Enterprises, Inc.

K-Number K222587

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BZD 2023-07-28

Therapy Mask 3100 NC/SP

Applicant Respironics, Inc.

K-Number K231313

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FMI 2023-07-27

Altaviz Needle Kit II

Applicant Altaviz, LLC

K-Number K231261

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FYA 2023-07-27

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets

Applicant Cardinal Health200, LLC

K-Number K230838

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EZL 2023-07-27

Teleflex Rusch SoftSimplastic Foley Catheters

Applicant Teleflexmedical, Inc.

K-Number K212077

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HWC 2023-07-27

IBS-B MIS Beveled Screw System

Applicant In2bones USA, LLC

K-Number K231236

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OHS 2023-07-27

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

Applicant iSMART Developments, Ltd.

K-Number K231555

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OLO 2023-07-27

SURGIVISIO Device

Applicant Ecential Robotics

K-Number K231886

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QFM 2023-07-27

Rapid Aneurysm Triage and Notification

Applicant Ischemaview, Inc.

K-Number K230074

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QOF 2023-07-27

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

Applicant Roche Molecular Systems, Inc.

K-Number K223591

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