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

IPF 2024-10-10

eMVFit (MVF-10M)

Applicant Weero Co., Ltd.

K-Number K240992

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PHX 2024-10-10

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

Applicant Stryker Corporation (Tornier, S.A.S.)

K-Number K241491

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MAX 2024-10-10

KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System

Applicant Ctl Medical Corporation

K-Number K233947

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QIH 2024-10-10

AutoChamber

Applicant HeartLung Corporation

K-Number K240786

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GEX 2024-10-10

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

Applicant Quanta System Spa

K-Number K241092

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QLU 2024-10-10

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K240315

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ONB 2024-10-10

ProSeal In Line Pump Set (423850)

Applicant Epic Medical Pte. , Ltd.

K-Number K241735

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MSS 2024-10-10

EyeGility Inserter for Preloaded enVista IOLs

Applicant Bausch & Lomb, Incorporated

K-Number K242389

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FAJ 2024-10-10

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance

Applicant Ambu A/S

K-Number K240848

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IZL 2024-10-10

uDR 380i Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K242515

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QIH 2024-10-10

EchoMeasure

Applicant Icardio.Ai

K-Number K241430

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GEX 2024-10-10

Lasya-Trinity

Applicant BLUECORE COMPANY Co., Ltd.

K-Number K241951

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