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

MNS 2024-12-13

Vivo 1, Vivo 2

Applicant Breas Medical AB

K-Number K240778

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CHL 2024-12-13

ABL90 FLEX PLUS System

Applicant Radiometer Medicals Aps

K-Number K240998

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FAJ 2024-12-13

Uro-G HD Cystoscope (1520)

Applicant Uroviu Corporation

K-Number K243196

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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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