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

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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PZI 2024-04-26

cobas pulse blood glucose monitoring system

Applicant Roche Diagnostics

K-Number K220272

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JIO 2024-04-26

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

Applicant Urit Medical Electronic Co., Ltd.

K-Number K232317

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EOB 2024-04-26

Rhinolaryngoscope system

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K232435

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GEI 2024-04-25

Kronos Electrocautery Device

Applicant Single Pass, Inc.

K-Number K232805

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