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

MBI 2023-08-02

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Applicant Gm Dos Reis Industria E Comerico Ltda.

K-Number K223114

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CFN 2023-08-02

Immunoglobulin G (IgG)

Applicant Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

K-Number K221114

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FED 2023-08-02

Disposable Ureteral Access Sheath

Applicant Youcare Technology Co.,Ltd. (Wuhan)

K-Number K230748

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OWN 2023-08-02

ActivSight Intraoperative Imaging System

Applicant Activ Surgical, Inc.

K-Number K231344

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GEI 2023-08-02

Eblator Device

Applicant E Surgical, LLC

K-Number K231126

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LNH 2023-08-02

Ingenia Elition R5.7.1 SP4 MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K232030

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ITX 2023-08-02

Disposable Needle Guides and Grids

Applicant Advance Medical Designs, Inc.

K-Number K223689

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KWQ 2023-08-02

Sapphire X3 Anterior Cervical Plate System

Applicant Spinal Elements, Inc.

K-Number K231593

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OLO 2023-08-02

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine

Applicant Brainlab AG

K-Number K223553

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FCM 2023-08-02

Self-Cath Closed System

Applicant Coloplast

K-Number K223821

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MOF 2023-08-01

Aristotle 18 Guidewire; Aristotle 24 Guidewire

Applicant Scientia Vascular, Inc.

K-Number K231954

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MQB 2023-08-01

EXPD 4357; EXPD 4357P

Applicant DRTECH Corporation

K-Number K231959

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