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

IYN 2024-11-15

The 5000 Compact Series Ultrasound Systems

Applicant Philips Ultrasound, LLC

K-Number K242800

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LZO 2024-11-15

b-ONE® Total Hip System

Applicant B-One Ortho, Corp.

K-Number K240528

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OLO 2024-11-15

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K243285

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IYN 2024-11-15

ACUSON Redwood Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K243299

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LLZ 2024-11-15

1CMR Pro

Applicant Mycardium AI Limited

K-Number K242062

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ELW 2024-11-15

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

Applicant Dent4you AG

K-Number K242360

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MQB 2024-11-15

VIVIX-S 1751S

Applicant Vieworks Co., Ltd.

K-Number K241125

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LIT 2024-11-15

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

Applicant Creagh Medical Ltd. Dba Surmodics, Inc.

K-Number K242419

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SDJ 2024-11-15

EchoGo Amyloidosis (1.0)

Applicant Ultromics Limited

K-Number K240860

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GEI 2024-11-15

ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator

Applicant Livsmed, Inc.

K-Number K241138

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N/A 2024-11-15

CORIOGRAPH Pre-Op Planning and Modeling Services

Applicant Blue Belt Technologies, Inc.

K-Number K242272

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DSY 2024-11-15

Gelsoft Plus Vascular Prostheses

Applicant Vascutek, Ltd.

K-Number K241070

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