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

FRC 2023-12-15

ConFirm 20 Minute Incubator

Applicant STERIS Corporation

K-Number K233681

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NXC 2023-12-15

Invisalign Palatal Expander System

Applicant Align Technology, Inc.

K-Number K232887

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OZI 2023-12-15

Double Internal Joint Stabilizer- Elbow

Applicant Skeletal Dynamics, Inc.

K-Number K231447

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OWB 2023-12-15

ARTIS pheno (VE30A)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K230949

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HEB 2023-12-15

Unscented Menstrual Tampon

Applicant Unibeauty (Hubei) Technology Co., Ltd.

K-Number K232598

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MUI 2023-12-15

Sterile and Non-Sterile Ultrasound Gels

Applicant Jianerkang Medical Co., Ltd.

K-Number K232957

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BZG 2023-12-15

Spirobank Oxi

Applicant Mir Medical International Research USA

K-Number K230501

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DXN 2023-12-15

Digital Blood Pressure Monitor (Model: YB-800)

Applicant Wenzhou Yosun Medical Technology Co.,Ltd

K-Number K231478

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QNP 2023-12-15

EW10-EC02 Endoscopy Support Program

Applicant Fujifilm Corporation

K-Number K230751

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OHT 2023-12-15

IPL Hair Removal Device

Applicant Shenzhen Borria Technology Co., Ltd.

K-Number K232939

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MCW 2023-12-15

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

Applicant Eximo Medical, Ltd.

K-Number K233668

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GEX 2023-12-15

xeo+ Family

Applicant Cutera, Inc.

K-Number K233237

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