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

EIH 2024-06-20

Copra Smile, Copra Supreme Hyperion

Applicant Whitepeaks Dental Solutions GmbH

K-Number K233158

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DPS 2024-06-20

DeepRhythm Platform

Applicant Medicalgorithmics S.A.

K-Number K232161

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GZF 2024-06-20

Freedom Peripheral Nerve Stimulator (PNS) System

Applicant Curonix

K-Number K233162

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HRS 2024-06-20

APTUS Elbow Dorsal Olecranon Plates

Applicant Medartis AG

K-Number K240613

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FDS 2024-06-19

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

Applicant Olympus Medical Systems Corporation

K-Number K232997

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LFL 2024-06-18

Ultrasonic Surgical System

Applicant Hunan Handlike Minimally Invasive Surgery Co., Ltd.

K-Number K233036

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FMF 2024-06-18

Pen Injector

Applicant Wuxi Nest Biotechnology Co., Ltd.

K-Number K240774

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OHT 2024-06-18

IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)

Applicant Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

K-Number K240583

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KNW 2024-06-18

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

Applicant Itp Innovative Tomography Products GmbH

K-Number K233294

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FRO 2024-06-18

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K-Number K240552

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NXC 2024-06-18

Invisalign System

Applicant Align Technology, Inc.

K-Number K241412

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HSB 2024-06-18

Fitbone Trochanteric

Applicant Orthofix Srl

K-Number K233867

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