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

OWB 2024-04-26

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl

Applicant Canon, Inc.

K-Number K232298

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MBH 2024-04-26

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)

Applicant Zimmer, Inc.

K-Number K240299

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LDF 2024-04-26

TME Temporary Myocardial Electrode

Applicant Osypka AG

K-Number K232261

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EOQ 2024-04-26

BioStar Single Use Transbronchial Aspiration Needle

Applicant Broncus Medical, Inc.

K-Number K232038

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HRS 2024-04-26

XLO Brand of Locking Distal Humerus Plating System

Applicant Ortho Life Systems Private Limited

K-Number K233873

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HAW 2024-04-26

Bone Anchor (NGS-BA-01)

Applicant ClearPoint Neuro, Inc.

K-Number K233703

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MUJ 2024-04-26

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232799

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IYN 2024-04-26

Sonio Detect

Applicant Sonio

K-Number K240406

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MAX 2024-04-26

Reef L Interbody System; WaveForm L Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K240566

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NKB 2024-04-26

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System

Applicant Clariance

K-Number K240872

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DZE 2024-04-26

NB Mini Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K240091

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IYO 2024-04-26

Pocket III

Applicant Quantel Medical

K-Number K232302

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