Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OAT 2023-08-21

ACR Screw System

Applicant Biomaterials Korea, Inc.

K-Number K222245

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OVE 2023-08-21

Stable-C Interbody System

Applicant Nexus Spine, LLC

K-Number K231763

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KPS 2023-08-21

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

Applicant Mcgovern Medical School

K-Number K231731

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QJP 2023-08-21

Plato 17 Microcatheter

Applicant Scientia Vascular, Inc.

K-Number K223560

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MXD 2023-08-19

LUX-Dx II (M302); LUX-Dx II+ (M312)

Applicant Boston Scientific Corp

K-Number K231328

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MOS 2023-08-18

1.5T HD T/R Knee Array (10-F34127)

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K231085

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OUP 2023-08-18

Avéli

Applicant Revelle Aesthetics, Inc.

K-Number K232153

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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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