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

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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HEB 2022-04-21

Tempo Tampon

Applicant Dong-A Pharmaceutical Co., Ltd.

K-Number K212277

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PHL 2022-04-21

GEMS-H

Applicant Samsung Electronics Co., Ltd.

K-Number K213452

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IZL 2022-04-21

GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K220175

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EBF 2022-04-21

Venus Bulk Flow ONE

Applicant Kulzer, LLC

K-Number K220605

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LZA 2022-04-21

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

Applicant Jiangsu Bytech Medical Supplies Co., Ltd.

K-Number K220382

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OOE 2022-04-21

FEMTO LDV Z8 Femtosecond Surgical Laser

Applicant Sie Ag,Surgical Instrument Engineering

K-Number K213559

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