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

GXN 2025-11-12

Synthes Patient Specific Implants

Applicant Synthes GmbH

K-Number K243715

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PKL 2025-11-12

Hemoclip

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K252271

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HRS 2025-11-12

WRISTAR MultiAx Distal Radius Kit

Applicant Intrauma S.P.A

K-Number K252959

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NEW 2025-11-12

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Applicant ETHICON, Inc.

K-Number K243897

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OWN 2025-11-12

VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

Applicant Olympus Medical Systems Corp.

K-Number K251336

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ITI 2025-11-12

Powered Wheelchair (PL001-9001)

Applicant Suzhou KD Intelligent Device Co., Ltd.

K-Number K252829

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NKG 2025-11-12

CMORE® CT System; CMORE® CT System Navigated Instruments

Applicant Icotec AG

K-Number K252327

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LPH 2025-11-12

EMPOWR Acetabular® Liner Extension

Applicant Encore Medical L.P.

K-Number K251833

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MUH 2025-11-10

EzSensor HD, EzSensor UHD

Applicant Qpix Solutions, Inc.

K-Number K252570

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PLR 2025-11-10

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System

Applicant Atlas Spine, Inc.

K-Number K252560

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DPS 2025-11-10

Withings BeamO (SCT02)

Applicant Withings

K-Number K252474

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GXN 2025-11-10

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Applicant KLS-Martin L.P.

K-Number K252573

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