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

QIH 2025-03-06

LVivo Seamless

Applicant Dia Imaging Analysis, Ltd.

K-Number K243331

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LON 2025-03-06

BD Phoenix Automated Microbiology System

Applicant Becton, Dickinson and Company

K-Number K250344

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JWH 2025-03-06

Persona® Revision Knee System (Persona Revision SoluTion Femoral Components)

Applicant Zimmer, Inc.

K-Number K243724

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DQK 2025-03-06

Intra-Operative Positioning System (IOPS®)

Applicant Centerline Biomedical, Inc.

K-Number K243842

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QNI 2025-03-06

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Applicant Miach Orthopaedics, Inc.

K-Number K243578

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NFO 2025-03-06

PureLift GLOW

Applicant Xtreem Pulse, LLC

K-Number K243587

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QAI 2025-03-06

XCELLARISPRO TWIST microneedling device

Applicant Dermaroller GmbH

K-Number K241790

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FRO 2025-03-06

Sterile Water USP and Sterile 0.9% Normal Saline USP

Applicant Laboratorios Biogalenic S.A. DE C.V.

K-Number K243001

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LZO 2025-03-06

Versacem Acetabular Shell and Double Mobility HC Liners

Applicant Medacta International S.A.

K-Number K241767

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PSY 2025-03-06

Philips IntelliSite Pathology Solution 5.1

Applicant Philips Medical Systems Nederland B.V.

K-Number K243871

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OLO 2025-03-05

Mako Total Hip Application 5.0

Applicant Mako Surgical Corp.

K-Number K243751

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DQX 2025-03-05

CROSSLEAD 0.018inch

Applicant Asahi Intecc Co., Ltd.

K-Number K242597

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