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

OUR 2023-09-28

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

Applicant Lesspine Innovations

K-Number K232605

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QBD 2023-09-28

DNA/RNA Shield SafeCollect Saliva Collection kit

Applicant Zymo Research

K-Number K231013

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KWI 2023-09-28

ALIGN Radial Head System

Applicant Skeletal Dynamics, Inc.

K-Number K231188

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FMF 2023-09-28

VeriSafe Safety sterile syringes

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K231792

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QAS 2023-09-28

Brainomix 360 Triage LVO

Applicant Brainomix Limited

K-Number K231837

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OHT 2023-09-28

IPL hair removal device

Applicant Lumenessa Corp

K-Number K232274

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QYE 2023-09-28

Low Ejection Fraction AI-ECG Algorithm

Applicant Anumana, Inc.

K-Number K232699

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GEX 2023-09-28

Hakon, Hakon Smart

Applicant Medical San Indústria DE Equipamentos Médicos Ltda.

K-Number K231901

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NGT 2023-09-27

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

Applicant Hantech Medical Device Co., Ltd.

K-Number K231363

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NKG 2023-09-27

VySpan PCT System

Applicant Vy Spine, LLC

K-Number K232167

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MUH 2023-09-27

EZSensor XHD

Applicant Qpix Solutions, Inc.

K-Number K232255

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DQK 2023-09-27

Volta AF-Xplorer

Applicant Volta Medical

K-Number K232616

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