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

QNP 2024-07-24

CADDIE

Applicant Odin Medical Limited

K-Number K240044

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KWQ 2024-07-24

FlexWing Anterior Cervical Plate System

Applicant Jeil Medical Corporation

K-Number K231251

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IYE 2024-07-24

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

Applicant Brainlab AG

K-Number K240431

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MZP 2024-07-24

Aptima HCV Quant Dx Assay

Applicant Hologic, Inc.

K-Number K233352

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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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