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

MAX 2024-07-17

sagAlign Lumbar Cage System (Various PNs)

Applicant Acuity Surgical Devices, LLC

K-Number K241413

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LNH 2024-07-16

Swoop® Portable MR Imaging® System

Applicant Hyperfine, Inc.

K-Number K240944

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FGB 2024-07-16

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K233778

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INI 2024-07-16

Electric Scooter (M2085, S2091)

Applicant Guangdong Prestige Technology Co., Ltd.

K-Number K240272

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KLE 2024-07-16

Light Cure Adhesive

Applicant Sincera Technology (Changchun) Co., Ltd.

K-Number K241056

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LIT 2024-07-16

Finesse Injectable PTA Balloon Dilatation Catheter

Applicant Summa Therapeutics

K-Number K241740

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NGL 2024-07-16

SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K241741

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PGY 2024-07-16

RadiForce RX670; RadiForce RX670-AR

Applicant Eizo Corporation

K-Number K241441

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SBG 2024-07-16

allay Nerve Cap

Applicant Tulavi Therapeutics

K-Number DEN230061

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KCT 2024-07-16

CrossRoads Modular Tray System

Applicant Crossroads Extremity Systems

K-Number K241050

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SBT 2024-07-15

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

Applicant Diasorin Molecular, LLC

K-Number DEN230092

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KPS 2024-07-15

NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat

Applicant Positrigo AG

K-Number K241751

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