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

EOQ 2022-06-16

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K220299

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LZA 2022-06-16

TC Gloves

Applicant Thanh Cong Pharmaceutical and Trading Company Limited

K-Number K221186

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HSX 2022-06-16

TLC Unicompartmental Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K212870

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EOQ 2022-06-16

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

Applicant OTU Medical, Inc.

K-Number K220399

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NBW 2022-06-16

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

Applicant Taidoc Technology Corporation

K-Number K201037

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LPH 2022-06-16

DePuy 3D Additive TriFlange Acetabular Cup

Applicant Depuy International, Ltd.

K-Number K201348

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NHA 2022-06-16

Dentis s-Clean Abutment Mini

Applicant Dentis Co., Ltd.

K-Number K220440

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JAK 2022-06-16

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

Applicant Canon Medical Systems Corporation

K-Number K213504

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LZA 2022-06-16

1st Glove Blue Nitrile Examination Gloves Powder Free

Applicant Koove Iot Pvt. , Ltd.

K-Number K221226

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MQB 2022-06-16

Wireless Digital Flat Panel Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K221345

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GWQ 2022-06-16

Seer Home

Applicant Seer Medical Pty, Ltd.

K-Number K212788

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LYZ 2022-06-16

Disposable Vinyl Examination Glove

Applicant Chifeng Huawei Medical Science&Technology Co., Ltd.

K-Number K220469

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