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 2025-07-14

Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

Applicant Shenzhen Fansizhe Science and Technology Co., Ltd.

K-Number K251173

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GEX 2025-07-14

Leonardo Duster

Applicant Ceramoptec GmbH

K-Number K250504

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QEZ 2025-07-14

FLOWRUNNER Aspiration System

Applicant Expanse Medical, Inc.

K-Number K251488

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QIH 2025-07-14

PeekMed web

Applicant Peek Health, S.A.

K-Number K251096

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DXN 2025-07-14

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Applicant Jiangxi Aicare Medical Technology Co., Ltd.

K-Number K250185

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N/A 2025-07-13

Welch Allyn Connex® 360 (Multiple)

Applicant Welch Allyn, Inc.

K-Number K243598

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POS 2025-07-12

NightWatch+ US

Applicant Livassured BV

K-Number K243199

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OHT 2025-07-11

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K250942

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NPM 2025-07-11

Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

Applicant Geistlich Pharma AG

K-Number K251786

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HBW 2025-07-11

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

Applicant Inion OY

K-Number K251472

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LNH 2025-07-11

Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K251808

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OHS 2025-07-11

KALA Therapy Wand (Model: KALA-03)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K250761

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