Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

PQO 2023-06-02

ADVIA Centaur® Anti-Müllerian Hormone (AMH)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K221801

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GEX 2023-06-02

SCAR 3

Applicant El.En Electroinc Engineering Spa

K-Number K231309

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DQY 2023-06-02

CPS Direct™ Universal slittable outer guide catheter (DS2C029)

Applicant ABBOTT MEDICAL

K-Number K231311

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EIH 2023-06-02

Harvest Conceal ZR Block Out

Applicant Harvest Dental Products, LLC

K-Number K222961

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FPA 2023-06-02

Volumat Line

Applicant Fresenius Kabi

K-Number K220301

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GWL 2023-06-01

SomniCheck

Applicant Brainmatterz, LLC

K-Number K223676

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JKA 2023-06-01

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

Applicant Sb-Kawasumi Laboratories, Inc.

K-Number K230408

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GEX 2023-06-01

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

Applicant Candela Corporation

K-Number K230990

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JTN 2023-06-01

HardyDisk AST Rezafungin 5µg (RZF5)

Applicant Hardy Diagnostics

K-Number K230827

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JAK 2023-06-01

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung

K-Number K223447

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LLZ 2023-06-01

Brainomix 360 e-CTP

Applicant Brainomix Limited

K-Number K223555

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MBI 2023-06-01

FiberTak® Suture Anchor

Applicant Arthrex, Inc.

K-Number K231330

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