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

OHT 2023-06-15

IPL Hair Removal Device Models: MLY-T069

Applicant Miley Technology (Hebei) Co., Ltd.

K-Number K230473

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CAH 2023-06-15

TNI Clear-Guard™ 3 angled breathing filter (1545020)

Applicant Intersurgical , Ltd.

K-Number K223258

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FRC 2023-06-15

Celerity Incubator

Applicant STERIS Corporation

K-Number K223715

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EOQ 2023-06-15

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

Applicant Olympus Medical Systems Corporation

K-Number K222861

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PLB 2023-06-15

SpassageQ

Applicant Spass, Inc.

K-Number K230386

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KWQ 2023-06-15

Zevo Anterior Cervical Plate System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K231090

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NKB 2023-06-15

EDEN Spinal Fixation MIS System

Applicant Jmt Co., Ltd.

K-Number K230762

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FGE 2023-06-15

WallFlex™ Biliary RX Stent System

Applicant Boston Scientific Corporation

K-Number K223469

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FRC 2023-06-15

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

Applicant STERIS Corporation

K-Number K223717

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OAP 2023-06-14

F65 Laser System

Applicant Lumenis Be, Ltd.

K-Number K222790

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BZE 2023-06-14

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

Applicant Draegerwerk AG & CO Kgaa

K-Number K222822

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MUM 2023-06-14

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K223067

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