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

NHA 2024-05-02

Neodent Implant System Custom Abutments

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K233857

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QXM 2024-05-02

Revi System

Applicant Bluewind Medical , Ltd.

K-Number K240037

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KRD 2024-05-02

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Applicant Merit Medical Systems, Inc.

K-Number K240261

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FBN 2024-05-02

Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps

Applicant CenterPoint Systems, LLC

K-Number K233752

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GKZ 2024-05-02

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies

K-Number K240636

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QEJ 2024-05-01

DuraGraft Vascular Conduit Solution

Applicant Marizyme

K-Number K240925

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EIH 2024-05-01

BruxZir® Esthetic

Applicant Prismatik Dentalcraft, Inc.

K-Number K240882

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NPL 2024-05-01

Soft Tissue Augmentation Resorbable Matrix

Applicant Collagen Matrix, Inc.

K-Number K233203

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LHI 2024-05-01

Vial Adapter with Filter

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K233284

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OLO 2024-05-01

Remex Spine Surgery Navigation System II

Applicant Remex Medical Corp.

K-Number K233513

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GEX 2024-05-01

ORskin Blue

Applicant Megabay S.A.

K-Number K232858

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QAT 2024-05-01

VIDAS TBI (GFAP, UCH-L1)

Applicant bioMerieux, Inc.

K-Number K240279

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