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

OHT 2025-05-06

IPL Hair Removal Device (KCA511/KCA516/KCA522)

Applicant Dongguan Boyuan Intelligent Technology Co.,Ltd

K-Number K250253

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OHT 2025-05-06

IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)

Applicant Foshan Newface Electronic Technology Co., Ltd.

K-Number K243017

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IZL 2025-05-06

!M1

Applicant Solutions For Tomorrow AB

K-Number K241980

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MLW 2025-05-05

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

Applicant Thermasolutions, LLC

K-Number K240447

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FYA 2025-05-05

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Applicant Dae Myung Chemical Co., Ltd. (Vietnam)

K-Number K242937

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MHX 2025-05-05

Telemetry Monitor 5500 Release 4.0 (867232)

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K242962

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DSH 2025-05-05

AeviceMD

Applicant Aevice Health Pte. , Ltd.

K-Number K243603

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MYN 2025-05-05

Second Opinion® Pediatric

Applicant Pearl, Inc.

K-Number K243893

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GCJ 2025-05-05

Arthrex Synergy Vision Endoscopic Imaging System

Applicant Arthrex, Inc.

K-Number K250728

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IRP 2025-05-05

ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)

Applicant Zamar Medical D.O.O.

K-Number K242754

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EBG 2025-05-05

DentaTOOTH

Applicant Asiga Pty, Ltd.

K-Number K243370

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EBZ 2025-05-05

Bluemoon

Applicant Genoss Co., Ltd.

K-Number K242386

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