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

HDX 2024-08-14

Intimate Rose Vaginal Dilators

Applicant Plus EV Holdings Dba Intimate Rose

K-Number K241748

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NGL 2024-08-14

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Applicant Qingdao Hightop Biotech Co., Ltd.

K-Number K241969

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GXD 2024-08-14

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

Applicant Avanos Medical, Inc.

K-Number K242057

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LLZ 2024-08-13

Bullsai

Applicant Turing Medical Technologies, Inc.

K-Number K241094

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ITI 2024-08-13

Power wheelchair (N6101)

Applicant Zhejiang Zhonglei Medical Technology Co. , Ltd.

K-Number K241686

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LCX 2024-08-13

Shinetell Digital Pregnancy Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K241978

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OUR 2024-08-13

SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System

Applicant Si-Technology, LLC

K-Number K241813

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LNH 2024-08-13

ECHELON Synergy MRI System

Applicant Fujifilm Healthcare Corporation

K-Number K241429

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HRS 2024-08-13

CoLink NeoFuse MIS Plating System (see attached parts list)

Applicant In2bones USA

K-Number K241387

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GEX 2024-08-13

SUPER VELOCE

Applicant Ilooda Co,., Ltd.

K-Number K241699

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CBK 2024-08-13

VM-2000

Applicant Ventis Medical, Inc.

K-Number K240807

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GEX 2024-08-13

Diode Laser Therapy Device (DF-DIODE LASER-S1)

Applicant Weifang Dragonfly Electronics Technology Co., Ltd.

K-Number K241547

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