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

QJI 2025-02-24

Control-IQ+ technology

Applicant Tandem Diabetes Care, Inc.

K-Number K243823

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LZC 2025-02-24

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Applicant Lingshi Hongruida Health Protection Technology Co., Ltd.

K-Number K243959

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OHV 2025-02-24

Ulthera® System

Applicant Ulthera, Inc.

K-Number K243035

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DZE 2025-02-24

SD Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K241703

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MQB 2025-02-24

ExamVue Apex

Applicant Jpi Healthcare Co, Ltd.

K-Number K244010

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FRG 2025-02-24

Sterilization Package/Reel

Applicant Anqing Clean Dental Instrument Technology Co., Ltd.

K-Number K241565

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NRY 2025-02-24

APRO 70 Swift Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K243287

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FRG 2025-02-21

Medicom Sterilization Pouch and Reel

Applicant Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.

K-Number K243431

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LLZ 2025-02-21

QuickRad

Applicant Aikenist Technologies Pvt, Ltd.

K-Number K242838

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FRG 2025-02-21

Sterilization Pouches and Reels

Applicant Shanghai Jianzhong Medical Packaging Co., Ltd.

K-Number K242898

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OLO 2025-02-21

Paradigm System

Applicant Proprio, Inc.

K-Number K243258

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NPR 2025-02-21

Xpert® FII & FV

Applicant Cepheid

K-Number K250218

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