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

KRA 2023-04-10

Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister

Applicant Argon Medical Devices, Inc.

K-Number K223176

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IYE 2023-04-10

ARIA Radiation Therapy Management (v18.0)

Applicant Varian Medical Systems, Inc.

K-Number K230699

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OHT 2023-04-10

IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02

Applicant Shenzhen Jizhimei Technology Co., Ltd.

K-Number K230360

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NRY 2023-04-10

APRO 70 Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K230695

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DXN 2023-04-10

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor

Applicant Famidoc Technology Company Limited

K-Number K222887

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KPR 2023-04-10

DMX

Applicant Del Medical, Inc.

K-Number K223550

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OAS 2023-04-07

Dental CT Scanner AXR

Applicant Alliage S/A Industrias Medico Odontológica

K-Number K223816

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LLZ 2023-04-07

Limbus Contour

Applicant Limbus Ai, Inc.

K-Number K230575

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JXI 2023-04-07

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Applicant Axogen Corporation

K-Number K223640

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KRH 2023-04-07

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

Applicant Corcym S.r.l.

K-Number K230318

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OLO 2023-04-07

Mazor X System (Mazor X Stealth Edition)

Applicant Mazor Robotics , Ltd.

K-Number K230064

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QVX 2023-04-07

The N-SWEAT Patch

Applicant Candesant Biomedical, Inc.

K-Number DEN210055

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