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

GEI 2022-08-01

CellFX® System

Applicant Pulse Biosciences, Inc.

K-Number K221671

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LZA 2022-08-01

Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Applicant O&M Halyard, Inc.

K-Number K213929

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MHX 2022-08-01

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

Applicant Caf Medical Solutions, Inc.

K-Number K221616

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LZA 2022-07-30

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid

Applicant Onetexx Sdn Bhd

K-Number K221773

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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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