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

LOX 2023-04-11

POT PTCA Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K230705

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OAS 2023-04-11

RCT800

Applicant Ray Co., Ltd.

K-Number K230753

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IYN 2023-04-11

Ultrasound System 2300

Applicant Bk Medical Aps

K-Number K223830

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NTE 2023-04-11

ENROUTE® Transcarotid Neuroprotection System

Applicant Silk Road Medical

K-Number K230402

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LLZ 2023-04-11

Augmento

Applicant Deeptek Medical Imaging Private Limited

K-Number K222781

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MUH 2023-04-11

Eagle S/Saevo Slim/D700 Slim

Applicant Alliage S/A Industrias Medica Odontológico.

K-Number K230732

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OWN 2023-04-11

L12 LED Light Source with AIM

Applicant Stryker

K-Number K230754

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GZF 2023-04-11

Neuspera Nuity System

Applicant Neuspera Medical, Inc.

K-Number K221303

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NUH 2023-04-10

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K-Number K230164

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OHT 2023-04-10

IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K230122

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PHX 2023-04-10

Arthrex Univers Revers Monoblock Stem Size 4/33

Applicant Arthrex, Inc.

K-Number K230366

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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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