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

KGN 2024-02-02

Corplex P / Theracor P / Allacor P

Applicant Stimlabs, LLC

K-Number K231325

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QEW 2024-02-02

Indigo® Aspiration System - Lightning® Flash

Applicant Penumbra, Inc.

K-Number K240030

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HTN 2024-02-02

OIC FLEX-FIX System

Applicant Orthopaedic Implant Company

K-Number K233531

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KDI 2024-02-02

5008X Hemodialysis System

Applicant Fresenius Medical Care

K-Number K231534

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JKA 2024-02-02

BD Vacutainer® K2 EDTA Blood Collection Tubes

Applicant Becton, Dickinson and Company

K-Number K231373

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LLZ 2024-02-01

CAAS MR Solutions

Applicant Pie Medical Imaging BV

K-Number K232007

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FYA 2024-02-01

Surgical Gown (40083)

Applicant Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K-Number K233183

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DQY 2024-02-01

WATCHMAN TruSteer Access System (M635TU90050)

Applicant Boston Scientific Corporation

K-Number K240018

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JAQ 2024-02-01

Kelowna GYN and Crook Prostate Templates

Applicant Varian Medical Systems, Inc.

K-Number K232949

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LLZ 2024-02-01

Augmented Reality Application

Applicant Sira Medical, Inc.

K-Number K232339

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FMI 2024-02-01

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles

Applicant Berpu Medical Technology Co., Ltd.

K-Number K232165

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GEX 2024-02-01

Resonic Rapid Acoustic Pulse Device

Applicant Zeltiq Aesthetics, Inc.

K-Number K233804

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