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

JWH 2024-10-25

BKS Revision System

Applicant Ortho Development Corp.

K-Number K242984

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OYK 2024-10-25

Cadence Ankle PSI System

Applicant 3D Systems, Inc.

K-Number K243174

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IYN 2024-10-24

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

Applicant Telefield Medical Imaging (Shenzhen) Limited

K-Number K241554

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IOR 2024-10-24

Manual Wheelchair (SYIV100-CA9221)

Applicant Foshan Shunkangda Medical Tech Co., Ltd.

K-Number K242560

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GEX 2024-10-24

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

Applicant Medency S.R.L.

K-Number K240543

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EIH 2024-10-24

ArgenZ MTZ

Applicant Argen Corporation

K-Number K242458

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SAH 2024-10-24

MagDI System (MAG-01, DS-01)

Applicant Gt Metabolic Solutions, Inc.

K-Number K242086

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LLZ 2024-10-24

ROCC Console

Applicant Philips Medical Systems Nederland B.V.

K-Number K242512

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LZO 2024-10-24

MUTARS® femoral stem cemented 160 mm and 200 mm

Applicant Implantcast GmbH

K-Number K240391

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DXN 2024-10-24

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K241007

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PCB 2024-10-24

Duet External Drainage and Monitoring System (EDMS)

Applicant Medtronic Neurosurgery

K-Number K242034

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EBI 2024-10-24

KeyPrint KeyDenture Base

Applicant Keystone Industries

K-Number K241089

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