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

QFJ 2023-05-25

Saranas Early Bird Bleed Monitoring System

Applicant Saranas, Inc.

K-Number K230273

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MLR 2023-05-25

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K-Number K231169

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FQH 2023-05-25

Armis VeriCyn Wound Wash

Applicant Armis Biopharma, Inc.

K-Number K220759

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LRC 2023-05-25

BB 8 Sinus Dilation Kit

Applicant Excelent, Inc.

K-Number K230258

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LBH 2023-05-25

Dental Desensitizer

Applicant Guangzhou Beogene Biotech Co., Ltd.

K-Number K222891

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DQY 2023-05-25

Stingray LP Catheter

Applicant Boston Scientific

K-Number K231176

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OLO 2023-05-25

S-COMP Reform® POCT Navigation Instruments

Applicant Precision Spine, Inc.

K-Number K231229

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HRS 2023-05-25

KLS Martin LINOS Wrist System

Applicant KLS-Martin L.P.

K-Number K222624

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NKB 2023-05-25

Advanced LumFix Spinal Fixation System

Applicant CG Bio Co., Ltd.

K-Number K222229

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DZE 2023-05-25

Genesis ACTIVE Implant System

Applicant Keystone Dental, Inc.

K-Number K223814

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BTL 2023-05-24

Oxymag - Transport and Emergency Ventilator

Applicant Magnamed Tecnologia Medica S/A

K-Number K221634

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NHA 2023-05-24

s-Clean Link Abutment Narrow

Applicant Dentis Co., Ltd.

K-Number K230523

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