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

EHD 2022-04-22

HYBRID S70

Applicant Digimed Co., Ltd.

K-Number K220574

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IYN 2022-04-22

SONON Ultrasound Imaging System, Model: SONON 500L

Applicant Healcerion Co., Ltd.

K-Number K212400

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KNW 2022-04-22

Promisemed Fine Biopsy Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K213683

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GCJ 2022-04-22

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)

Applicant Stryker

K-Number K220895

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HRS 2022-04-22

RibFix Blu Thoracic Fixation System

Applicant Biomet Microfixation

K-Number K212608

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JAK 2022-04-22

HealthOST

Applicant Nanoxai , Ltd.

K-Number K213944

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GEX 2022-04-22

PicoStar

Applicant Asclepion Laser Technologies GmbH

K-Number K213889

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MYN 2022-04-21

Videa Caries Assist

Applicant Videahealth, Inc.

K-Number K213795

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LZA 2022-04-21

Ivory Glove Powder-Free Nitrile Examination Gloves

Applicant Ivory Gloves Sdn. Bhd.

K-Number K213681

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NEU 2022-04-21

HydroMARK Breast Biopsy Site Marker

Applicant Devicor Medical Products, Inc.

K-Number K212158

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GEX 2022-04-21

Waterlase iPLus

Applicant Biolase, Inc.

K-Number K210183

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JOM 2022-04-21

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

Applicant Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

K-Number K213730

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