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

MAX 2026-01-23

Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K253748

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DJG 2026-01-23

Evidence MultiSTAT DOA Urine MultiPlex

Applicant Randox Laboratories Limited

K-Number K250741

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OHS 2026-01-23

LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

Applicant Shenzhen Rainbow Technology Co., Ltd.

K-Number K253712

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NHA 2026-01-22

Straumann Variobase Abutments XC for Bridge/Bar

Applicant Institut Straumann AG

K-Number K253315

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PPU 2026-01-22

PhenoMATRIX

Applicant Copan Wasp Srl

K-Number K251511

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DYB 2026-01-22

Genie MAX Large Bore Introducer Sheath

Applicant Cultiv8 1, LLC

K-Number K253652

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PML 2026-01-22

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K252885

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HGX 2026-01-22

Pump In Style® Pro+

Applicant Medela, LLC

K-Number K253498

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FLE 2026-01-22

Getinge GSS67N Series Steam Sterilizer

Applicant Maquet GmbH (A Getinge Group Company)

K-Number K252307

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NHA 2026-01-22

IPDmilled Blanks

Applicant Implant Protesis Dental 2004, S.L.

K-Number K253253

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QIH 2026-01-22

AV Vascular

Applicant Philips Medical Systems Nederland B.V.

K-Number K253735

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PHX 2026-01-22

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

Applicant Lima Corporate S.P.A.

K-Number K252352

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