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

PNP 2024-12-26

Straumann CARES Visual and Nova Dental CAD

Applicant Institut Straumann AG

K-Number K233252

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GEI 2024-12-26

RM STAR EX with RMS Needle

Applicant Bomtech Electronics Co., Ltd.

K-Number K243097

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ONB 2024-12-26

ProSeal™ Vented Universal Vial Adaptor

Applicant Epic Medical Pte. , Ltd.

K-Number K240517

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GEX 2024-12-26

Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)

Applicant Jiangxi Medex Technology Co., Ltd.

K-Number K243141

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JDR 2024-12-26

TMC Compression Implant System

Applicant Treace Medical Concepts

K-Number K243658

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FMF 2024-12-24

Insulin Syringes

Applicant Chirana T. Injecta

K-Number K242434

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SBF 2024-12-24

SpineAR SNAP (SyncAR Spine)

Applicant Surgical Theater, Inc.

K-Number K243623

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SDT 2024-12-23

SIMEOX 200 Airway Clearance Device

Applicant Inogen, Inc.

K-Number K241091

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EBI 2024-12-23

Denture Base

Applicant Riton 3D Technology Co., Ltd.

K-Number K243103

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PKC 2024-12-23

INHANCE INTACT™

Applicant Depuy Ireland UC

K-Number K243248

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LNH 2024-12-23

NIDO Baby Magnetic Resonance Imaging System

Applicant Jiangsu Lici Medical Device Co., Ltd.

K-Number K242573

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HRS 2024-12-23

ARTFX Trauma Bone Plate and Screw System

Applicant Artfx Medical

K-Number K242939

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