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

OLO 2025-11-13

Rosa® Knee System

Applicant Orthosoft Inc. (d/b/a) Zimmer CAS

K-Number K251314

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IRP 2025-11-13

Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)

Applicant Shenzhen Future Electronic Co., Ltd.

K-Number K251662

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QIH 2025-11-12

PeekMed web

Applicant Peek Health, S.A.

K-Number K252452

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PGZ 2025-11-12

XSTAT P15

Applicant Revmedx, Inc.

K-Number K253290

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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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