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

DXT 2024-12-23

Angiography Injector

Applicant Shandong Int Medical Instruments Co., Ltd.

K-Number K242143

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OMP 2024-12-23

Genadyne DUO NPWT

Applicant Genadyne Biotechnologies, Inc.

K-Number K233614

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MQV 2024-12-23

GlassBone Granules

Applicant Noraker

K-Number K242782

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QME 2024-12-23

PanopticAI Vital Signs

Applicant PanopticAI technologies Limited

K-Number K240890

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GEI 2024-12-23

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

Applicant Beijing Taktvoll Technology Co., Ltd.

K-Number K240975

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MQV 2024-12-23

OsteoFlo HydroFiber

Applicant SurGenTec, LLC

K-Number K242797

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IRP 2024-12-23

SACS PRO

Applicant Elastimed , Ltd.

K-Number K243177

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FMF 2024-12-23

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

Applicant Hlb Lifescience Co., Ltd.

K-Number K241856

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HTN 2024-12-23

Bolo Button System

Applicant Fusion Orthopedics

K-Number K242091

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JAA 2024-12-23

Adora DRFi (04550010)

Applicant Nrt X-Ray A/S

K-Number K242948

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JAK 2024-12-23

Aquilion ONE (TSX-308A/3) V1.5

Applicant Canon Medical Systems Corporation

K-Number K242403

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NKB 2024-12-23

NEO Pedicle Screw System™

Applicant Neo Medical SA

K-Number K243693

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