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

DQY 2023-11-17

SENDERO Microcatheter

Applicant Okami Medical, Inc.

K-Number K231600

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LZA 2023-11-17

DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K232538

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QSY 2023-11-17

Celox Rapid X-Ray Gauze

Applicant Medtrade Products , Ltd.

K-Number K230589

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FDS 2023-11-17

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

Applicant Iq Endoscopes Limited

K-Number K232028

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NHA 2023-11-17

Multi-Unit DAS System

Applicant Talladium España, SL

K-Number K231559

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JAK 2023-11-16

CT Lung Ventilation Analysis Software (CT:V)

Applicant 4Dmedical Limited

K-Number K232392

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LPL 2023-11-16

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens

Applicant Innova Vision, Inc.

K-Number K232139

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LPL 2023-11-16

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric

Applicant Alcon Laboratories, Inc.

K-Number K232921

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DTZ 2023-11-16

D100 KIDS; D101 KIDS

Applicant Sorin Group Italia S.R.L.

K-Number K231652

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MQB 2023-11-16

EXPD 4343D; EXPD 3643D

Applicant DRTECH Corporation

K-Number K232753

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NIE 2023-11-16

Trio-CT® Triple Lumen Catheter w/ Curved Extensions

Applicant Medical Components, Inc. (dba MedComp)

K-Number K232945

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MNU 2023-11-16

OSSIOfiber® Compression Staple

Applicant OSSIO , Ltd.

K-Number K233302

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