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

MBF 2023-11-13

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

Applicant Depuy Ireland UC

K-Number K230831

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NEY 2023-11-13

Microwave Ablation System (BD-GT)

Applicant Betters(Suzhou) Medical Co., Ltd.

K-Number K232240

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QIH 2023-11-13

BriefCase-Quantification

Applicant Aidoc Medical , Ltd.

K-Number K232083

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FAJ 2023-11-13

Cystoscope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K231118

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QIH 2023-11-13

Clarius Bladder AI

Applicant Clarius Mobile Health Corp.

K-Number K232257

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FMK 2023-11-13

Accu-Chek Safe-T-Pro Plus Lancing Device

Applicant Roche Diabetes Care, Inc.

K-Number K232488

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NEY 2023-11-13

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Applicant Betters(Suzhou) Medical Co., Ltd.

K-Number K232241

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OQY 2023-11-13

ELLAVI UBT

Applicant Sinapi Biomedical (Pty) , Ltd.

K-Number K230849

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KGN 2023-11-13

Foundation Dermal Regeneration Scaffold (DRS) Solo

Applicant Bionova Medical, Inc.

K-Number K231937

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FMK 2023-11-13

Accu-Chek Safe-T-Pro Uno Lancing Device

Applicant Roche Diabetes Care, Inc.

K-Number K232509

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FRO 2023-11-10

Skin and Wound Cleanser

Applicant Winner Medical Co., Ltd.

K-Number K231564

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GWQ 2023-11-09

Neuronaute Plus

Applicant Bioserenity Sas

K-Number K231366

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