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

HWC 2023-07-18

Forma Medical Headless Compression Screw

Applicant Forma Medical, Inc.

K-Number K230945

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FLL 2023-07-18

FMT Reusable Temperature Probes

Applicant Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti

K-Number K213100

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DZE 2023-07-18

Bone Chamber Implant

Applicant Megagen Implant Co., Ltd.

K-Number K223339

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FMF 2023-07-18

Hypodermic Syringes & Needle

Applicant Lifelong Meditech Private Limited

K-Number K222925

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PNP 2023-07-18

TRUST

Applicant Rgorithm Korea

K-Number K221107

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FMF 2023-07-17

Avitus® DragonWing Large Volume Autograft Delivery System

Applicant Avitus Orthopaedics, Inc.

K-Number K231456

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GEX 2023-07-17

LaserME

Applicant Neauvia North America

K-Number K230077

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FXX 2023-07-17

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

Applicant Durio Ppe Sdn Bhd

K-Number K230395

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OWN 2023-07-17

FloNavi Open Field Fluorescence Imaging System

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K230407

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HSN 2023-07-17

OPTIX H2 Patient Specific Instrument System

Applicant Vilex, LLC

K-Number K230462

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DQA 2023-07-17

Pulse Oximeter

Applicant Shenzhen Brav Electronic Technologies Co., Ltd.

K-Number K211143

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LLZ 2023-07-17

Fibroid Mapping Reviewer Application (FMRA)

Applicant Nesa Medtech Private Limited

K-Number K222683

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