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

FED 2023-07-28

Pathfinder Endoscope Overtube with Balloon Device

Applicant Neptune Medical, Inc.

K-Number K230801

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QDG 2023-07-28

FLUOBEAM® LX Red

Applicant Fluoptics Sas

K-Number K230898

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BZR 2023-07-28

FlowStar Touch Digital Mixer Flowmeter

Applicant Baldus Sedation GmbH & Co. KG

K-Number K222794

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PJD 2023-07-28

Quantisal II Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K223781

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FXX 2023-07-28

3 Layer Surgical Mask (134252531)

Applicant Original Mattress Factory, Inc.

K-Number K231618

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PEA 2023-07-28

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

Applicant Pentax of America, Inc.

K-Number K231249

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NKB 2023-07-28

Adena-Zina Spinal System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K231931

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DPS 2023-07-28

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

Applicant Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

K-Number K223670

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NDC 2023-07-28

BlueStar and BlueStar Rx

Applicant Welldoc, Inc.

K-Number K230813

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GWG 2023-07-28

HJY VisualNext Endoscopic Vision System

Applicant Hjy Smart Medical Device Co., Ltd.

K-Number K222735

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KIF 2023-07-28

Bright MTA Sealer Plus

Applicant Genoss Co., Ltd.

K-Number K231480

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QAI 2023-07-28

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

Applicant Esthetic Medical, Inc.

K-Number K231073

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