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

JAK 2022-07-29

Deep Learning Image Reconstruction

Applicant Ge Healthcare Japan Corporation

K-Number K220961

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NHA 2022-07-29

NobelProcera Zirconia N1 Base

Applicant Nobel Biocare Services AG

K-Number K220048

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FBK 2022-07-29

Injection Needle

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K213914

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QBJ 2022-07-29

Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K221259

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FOA 2022-07-29

EleGARD

Applicant Advancedcpr Solutions, LLC

K-Number K221901

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QSY 2022-07-29

Vascette HP (hemostatic pad)

Applicant Koag, LLC

K-Number K220566

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CCK 2022-07-29

Microstream CO2 NanoPod

Applicant Covidien, LLC

K-Number K213911

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SBF 2022-07-29

OptiVu ROSA MxR

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K220733

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MBI 2022-07-29

Auxilock Titanium Screw-In Suture Anchor

Applicant Auxein Medical Private Limited

K-Number K213104

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BSP 2022-07-29

Medispine - Spinal Needle, Glospine - Spinal Needle

Applicant Global Medikit Limited

K-Number K212982

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EIH 2022-07-29

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Hunan Vsmile Biotechnology Co., Ltd.

K-Number K221242

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KDI 2022-07-29

Tablo Hemodialysis System

Applicant Outset Medical, Inc.

K-Number K211370

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