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

GCJ 2023-08-18

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Applicant Stryker Corporation

K-Number K232157

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GEX 2023-08-18

Holmium Medical Laser

Applicant Allengers Global Healthcare Private Limited

K-Number K231718

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GWQ 2023-08-18

SPARK Scan

Applicant Spark Neuro, Inc.

K-Number K231457

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NHA 2023-08-18

Eco Abutment, Multiunit Abutment

Applicant Dio Corporation

K-Number K220253

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GEI 2023-08-18

Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)

Applicant Olympus Winter & Ibe GmbH

K-Number K231777

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HRS 2023-08-18

Pangea Utility Plating System, Pangea Platform

Applicant Stryker GmbH

K-Number K231257

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ODP 2023-08-18

ZSFab Cervical Interbody System

Applicant Zsfab, Inc.

K-Number K232150

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MNR 2023-08-18

Onera Sleep Test System (Onera STS)

Applicant Onera B.V.

K-Number K223573

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NUH 2023-08-18

Unicare (K-UNICARE-USA)

Applicant Tenscare, Ltd.

K-Number K231053

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HRS 2023-08-18

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System

Applicant Stryker GmbH

K-Number K231262

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KPM 2023-08-18

Automatic Continuous Effusion Shunt (ACES) System ACES System

Applicant Pleural Dynamics, Inc.

K-Number K231096

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OLZ 2023-08-18

Dreem 3S

Applicant Beacon Biosignals, Inc.

K-Number K223539

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