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

IYN 2022-07-15

Vivid S60N, Vivid S70N

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K220619

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BZG 2022-07-15

ComPAS2

Applicant Morgan Scientific, Inc.

K-Number K213872

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GWL 2022-07-15

NomadAir PMU810

Applicant Neurotronics, Inc.

K-Number K220631

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LFL 2022-07-15

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K221763

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FPL 2022-07-15

NxtGen Infant Transport Incubator

Applicant International Biomedical

K-Number K220742

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OBP 2022-07-15

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

Applicant Neuronetics, Inc.

K-Number K220127

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DZE 2022-07-15

Tatum Surgical Dental Implant System

Applicant Suncoast Dental, Inc. Dba Tatum Surgical

K-Number K213576

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HQF 2022-07-15

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Applicant Lumenis Be, Inc.

K-Number K220877

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DZE 2022-07-15

Kontact Dental Implant System

Applicant Biotech Dental, Sas

K-Number K213997

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JXI 2022-07-15

Nerve Tape

Applicant Biocircuit Technologies, Incorporated

K-Number K210665

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CAF 2022-07-15

Hailie Sensor NF0106

Applicant Adherium (Nz), Ltd.

K-Number K220622

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GEI 2022-07-15

Renuvion APR Handpiece

Applicant Apyx Medical Corporation(Formerly Bovie Medical Corporation)

K-Number K220970

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