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

QBJ 2023-03-03

FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K222447

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JAK 2023-03-03

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

Applicant Canon Medical Systems Corporation

K-Number K222819

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LLZ 2023-03-03

CoverScan (CoverScan v1.1)

Applicant Perspectum

K-Number K230294

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KPO 2023-03-03

NIKKICART

Applicant Renal Care Dialysis Solutions, S.A. DE C.V.

K-Number K221652

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DXC 2023-03-03

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Applicant Compression Works, Inc.

K-Number K221661

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DWM 2023-03-03

Aspira Pleural Drainage System

Applicant Merit Medical Systems, Inc.

K-Number K212696

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KLE 2023-03-03

EZ Bond Universal

Applicant Meta Biomed Co., Ltd.

K-Number K230009

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MAX 2023-03-03

PEEK Spinal Infusion Cage

Applicant Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K-Number K223776

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MBI 2023-03-03

Grappler Suture Anchor R3FLEX IOL System

Applicant Paragon 28, Inc.

K-Number K223589

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HGX 2023-03-03

imani i2Plus Breast Pump

Applicant Imani Co.

K-Number K222573

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KNT 2023-03-03

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

Applicant Endolumik, Inc.

K-Number K222880

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EHD 2023-03-03

DHX-70H, XTG-70H

Applicant Digimed Co., Ltd.

K-Number K221587

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