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

EKX 2023-04-26

Endo Motor

Applicant Shenzhen Perfect Medical Instruments Co., Ltd.

K-Number K222548

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QIH 2023-04-25

Ceevra Reveal 3

Applicant Ceevra, Inc.

K-Number K222676

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KRA 2023-04-25

Wallaby 017 Micro Catheter

Applicant Wallaby Medical

K-Number K223139

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JAK 2023-04-25

iCAC Device

Applicant Bunkerhill, Inc.

K-Number K230223

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ODP 2023-04-25

NITRO Interbody Fusion Cage System Family

Applicant Ctl Medical Corporation

K-Number K220513

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OHT 2023-04-25

IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG

Applicant Shenzhen Xiazhifeng Electronic Co., Ltd.

K-Number K230549

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DRF 2023-04-25

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable

Applicant Boston Scientific

K-Number K230503

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PDU 2023-04-25

Tigereye ST CTO-Crossing Catheter

Applicant Avinger, Inc.

K-Number K230594

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QIS 2023-04-25

MiVu Esophageal Endo Cap

Applicant Diversatek Healthcare

K-Number K230056

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NHA 2023-04-25

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

Applicant Dental Direkt GmbH

K-Number K230218

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LLZ 2023-04-25

Konicaminolta DI-X1

Applicant Konica Minolta, Inc.

K-Number K230906

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OLO 2023-04-25

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K230202

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