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

DJG 2023-07-31

AllTest Fentanyl Rapid Test (Urine)

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K231698

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QOF 2023-07-31

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System

Applicant Bd Integrated Diagnostic Solutions /

K-Number K230956

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FGB 2023-07-31

RenaNav Ureteroscope System

Applicant CenterPoint Systems, LLC

K-Number K223097

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POW 2023-07-31

V-Print c&b temp

Applicant Voco GmbH

K-Number K231591

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GAP 2023-07-31

Surgical Sutures with or without Needle

Applicant Huaian Seamen Medical Technology Co., Ltd.

K-Number K221767

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OHT 2023-07-31

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

Applicant Zhuzhou Goldenhot Medical Technology Co., Ltd.

K-Number K231613

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GEX 2023-07-30

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

Applicant Lotuxs Medtech (Suzhou) Co., Ltd.

K-Number K222862

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DPS 2023-07-28

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

Applicant Edan Instruments, Inc.

K-Number K222902

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CGA 2023-07-28

i-STAT CG8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K223710

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EMA 2023-07-28

Dia-Cem

Applicant DiaDent Group International

K-Number K231552

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OUR 2023-07-28

SI-Cure Sacroiliac Joint Fusion System

Applicant Alevio, LLC

K-Number K231951

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KOC 2023-07-28

Blood Tubing Lines for Hemodialysis AV06C-E

Applicant NIKKISO CO., LTD.

K-Number K231589

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