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

DZE 2023-07-07

IH Implant System

Applicant Sewonmedix, Inc.

K-Number K222707

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OCX 2023-07-07

ANDORATE® Valve Kit

Applicant Ga Health Company Limited

K-Number K230932

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HTY 2023-07-06

Tyber Medical Pin and Wire System (various)

Applicant Tyber Medical, LLC

K-Number K231339

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GCJ 2023-07-06

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K231003

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OWW 2023-07-06

SpinMedix Absorbable Fibrous Membrane

Applicant Celestray Biotech Company, LLC.,

K-Number K222220

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BZD 2023-07-06

Whitsundays Mask System

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K-Number K223747

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MHX 2023-07-06

ARGUS PB-3000

Applicant Schiller AG

K-Number K221056

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GAT 2023-07-06

MyEllevate

Applicant Cynosure, LLC

K-Number K230510

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MNT 2023-07-06

Servo-air Lite Ventilator System

Applicant Maquet Critical Care AB

K-Number K230173

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EHD 2023-07-06

Lumos 3DX

Applicant 3Dio

K-Number K223780

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GEI 2023-07-06

VYBE RF Electrosurgical System

Applicant ShenB Co., Ltd.

K-Number K230968

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JTN 2023-07-06

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

Applicant Hardy Diagnostics

K-Number K231568

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