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

PLF 2024-11-08

Trigon PEEK HA Wedges

Applicant Nvision Biomedical Technologies

K-Number K243231

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GEI 2024-11-08

Superflow Prime Treatment System (ASP-1M)

Applicant Guangzhou Aimira Innovation Technology Co, Ltd.

K-Number K242286

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QDQ 2024-11-08

ProFound Detection (V4.0)

Applicant Icad, Inc.

K-Number K240417

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MLO 2024-11-08

Frontier X Plus

Applicant Fourth Frontier Technologies Pvt, Ltd.

K-Number K240794

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OAP 2024-11-08

Hair Growth Comb (SZ-23,SZ-23A)

Applicant Shenzhen Nuon Medical Equipment Co., Ltd.

K-Number K241342

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GEI 2024-11-08

Plasonic (Plasonic)

Applicant Hironic Co., Ltd.

K-Number K241099

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DYB 2024-11-08

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

Applicant Pulnovo Medical (Wuxi) Co., Ltd.

K-Number K242756

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ODC 2024-11-08

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

Applicant STERIS Corporation

K-Number K243075

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OHT 2024-11-07

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

Applicant Shenzhen Greatro Electronic Technology Co., Ltd.

K-Number K242595

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KWQ 2024-11-07

OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI

Applicant Stryker Spine

K-Number K242361

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KIF 2024-11-07

VioSeal

Applicant Spident Co., Ltd.

K-Number K242702

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JAQ 2024-11-07

Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve

Applicant Varian Medical Systems, Inc.

K-Number K241853

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