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

PDZ 2022-07-20

AF Laser

Applicant ShenB Co., Ltd.

K-Number K221363

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KTI 2022-07-20

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K213060

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DQY 2022-07-19

Selectra Lead Implantation System

Applicant Biotronik, Inc.

K-Number K222037

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OWB 2022-07-19

ARTIS icono (Ceiling Configuration)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K221516

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KRA 2022-07-19

MAGIC Flow-Dependent Microcatheter

Applicant Balt USA, LLC

K-Number K213435

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LZA 2022-07-19

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K220943

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FXX 2022-07-19

Surgical face mask

Applicant Hubei Qianjiang Kingphar Medical Material Co., Ltd.

K-Number K220777

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OHS 2022-07-19

Beauty LED Mask, Model: KFB265

Applicant Hunan Guangye Biotechnology Co., Ltd.

K-Number K221151

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DQK 2022-07-19

ZEUS System (Zio Watch)

Applicant iRhythm Technologies, Inc.

K-Number K213409

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QIH 2022-07-19

BrainInsight

Applicant Hyperfine, Inc.

K-Number K220815

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LIT 2022-07-19

Tiche PTA Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K212215

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DXH 2022-07-19

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

Applicant Verily Life Sciences, LLC

K-Number K213357

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