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

MIB 2024-07-24

MISTI Silicone Implant

Applicant Keosan Trading Co.

K-Number K241150

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EKX 2024-07-24

X-Smart Pro; X-Smart Pro+

Applicant Dentsply Sirona, Inc.

K-Number K233865

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DQK 2024-07-24

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)

Applicant Centerline Biomedical, Inc.

K-Number K241243

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NKB 2024-07-24

Erisma® Lp Spinal Fixation System; Erisma® LP MIS

Applicant Clariance

K-Number K241863

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PLB 2024-07-23

AITRICS-VC

Applicant Aitrics Co., Ltd.

K-Number K240756

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HRS 2024-07-23

Gaudi Proximal Humerus Plate

Applicant Netbiologics, LLC

K-Number K241296

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IYN 2024-07-23

TE Air Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K240906

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LLZ 2024-07-23

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

Applicant Ewoosoft Co., Ltd.

K-Number K241114

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JLW 2024-07-22

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

Applicant Genalyte, Inc.

K-Number K234091

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HSN 2024-07-22

Kinos Total Ankle System

Applicant Restor3D

K-Number K241482

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PDZ 2024-07-22

Onycho Laser V

Applicant Terasysd&C, Inc.

K-Number K241116

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IYN 2024-07-22

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K240704

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