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

DYB 2024-12-13

Agilis NxT Steerable Introducer Dual-Reach

Applicant ABBOTT MEDICAL

K-Number K243493

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GXY 2024-12-13

CAIs Sensor (CAIs-001)

Applicant Brainu Co., Ltd.

K-Number K241160

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MUJ 2024-12-13

ARIA Radiation Therapy Management System (18.1)

Applicant Varian Medical Systems, Inc.

K-Number K242463

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OLO 2024-12-13

Remex Spine Surgery Navigation Instrument

Applicant Remex Medical Corp.

K-Number K243560

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MWJ 2024-12-13

HeartBeam AIMIGo(TM) System

Applicant Heartbeam, Inc.

K-Number K231424

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NKB 2024-12-13

LOCK-IN Spinal Fixation System

Applicant Lock-In USA Corp

K-Number K243281

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OBO 2024-12-13

Anterion

Applicant Heidelberg Engineering GmbH

K-Number K240924

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OVD 2024-12-13

aprevo® anterior lumbar interbody fusion device with interfixation

Applicant Carlsmed, Inc.

K-Number K243635

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JAF 2024-12-13

Laminar P1 (LDH-HW-001)

Applicant Laminar Digital Health, Inc.

K-Number K242487

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FER 2024-12-13

Gastro Concepts Air Assist

Applicant Gastro Concepts, LLC

K-Number K242668

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MNT 2024-12-13

Vivo 3

Applicant Breas Medical AB

K-Number K240779

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OHT 2024-12-13

Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K241998

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