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

GEX 2022-07-19

Joule diVa System

Applicant Sciton, Inc

K-Number K213761

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IYN 2022-07-18

Vivid iq

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K221148

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JEY 2022-07-18

KLS Martin Individual Patient Solutions

Applicant KLS-Martin L.P.

K-Number K210731

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IYN 2022-07-18

Vivid T8, Vivid T9

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K221147

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MUE 2022-07-18

Planmed Clarity 2D, Planmed Clarify S

Applicant Planmed OY

K-Number K211720

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NPL 2022-07-18

OSSIX Breeze

Applicant Datum Dental, Ltd.

K-Number K212509

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LFL 2022-07-18

Ultrasonic Scalpel System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K212614

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IZL 2022-07-18

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

Applicant Sedecal., Sa.

K-Number K221803

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LZA 2022-07-16

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves

Applicant Zibo Blue Sail Health Technology Co., Ltd.

K-Number K221229

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QTI 2022-07-16

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

Applicant Becton, Dickinson and Company

K-Number K213955

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MQB 2022-07-15

Digital Radiography CXDI-Pro, Digital Radiography D1

Applicant Canon, Inc.

K-Number K221876

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QLX 2022-07-15

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

Applicant Abbott Molecular, Inc.

K-Number K212778

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