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

QVF 2024-04-19

Healgen Rapid COVID-19 Antigen Test

Applicant Healgen Scientific,, LLC

K-Number K232377

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QYT 2024-04-19

Flowflex® Plus COVID-19 Home Test

Applicant ACON Laboratories, Inc.

K-Number K233373

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QHW 2024-04-19

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K240534

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MHX 2024-04-19

Patient Monitor (iX10, iX12, iX15)

Applicant Edan Instruments, Inc.

K-Number K232962

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HRS 2024-04-19

APTUS Foot System 2.8-3.5

Applicant Medartis AG

K-Number K232105

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OHS 2024-04-19

FAQ 201, FAQ 202

Applicant Foreo, Inc.

K-Number K240378

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NKB 2024-04-19

NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System

Applicant SeaSpine Orthopedics Corporation

K-Number K232566

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QSY 2024-04-19

Hemoblock_S (Prescription); Hemoblock_S (OTC)

Applicant Incore Co., Ltd.

K-Number K232216

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IZQ 2024-04-19

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K-Number K233737

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KGN 2024-04-19

Miro3D Fibers Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K240753

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GZJ 2024-04-19

Electrical Neuromuscular Stimulator, Cure Trio

Applicant Oriental Inspiration Limited

K-Number K233046

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FOZ 2024-04-19

AccuCath Ace Intravascular Catheter

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K233106

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