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

HWC 2022-08-03

Cannulated Screws

Applicant Maxxion Medical, LLC

K-Number K213614

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DSH 2022-08-02

QOCA Portable ECG Monitoring Device

Applicant Quanta Computer, Inc.

K-Number K210179

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EIH 2022-08-02

BruxZir NOW

Applicant Prismatik Dentalcraft, Inc.

K-Number K220816

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KYF 2022-08-02

iStent infinite Trabecular Micro-Bypass System, Model iS3

Applicant Glaukos Corporation

K-Number K220032

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OHT 2022-08-01

IPL hair removal

Applicant Shenzhen Lizbella Technology Co.,Ltd

K-Number K221451

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FLE 2022-08-01

Consolidated HC Steam Sterilizer

Applicant Consolidated Machine Corp.

K-Number K220736

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LZA 2022-08-01

Disposable Medical Nitrile Examination Gloves

Applicant Fujian Jixiang Medical Technology Co.,Ltd

K-Number K220237

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MQB 2022-08-01

X-ray Flat Panel Detectors (CareView 1800 RF)

Applicant Careray Digital Medical Technology Co., Ltd.

K-Number K221549

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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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