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

MAX 2023-05-16

Eminent Spine 3D Lumbar Interbody Fusion Systems

Applicant Eminent Spine, LLC

K-Number K230219

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OHS 2023-05-16

Infrared Heat (Model: E0221)

Applicant Light Tree Ventures Europe B.V.

K-Number K223893

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ELC 2023-05-15

Combi Touch

Applicant Mectron S.P.A.

K-Number K231391

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QBJ 2023-05-15

Dexcom G7 Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K231081

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NHA 2023-05-15

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

Applicant Institut Straumann AG

K-Number K222836

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PHW 2023-05-15

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

Applicant Mmj Labs, LLC

K-Number K202993

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DRG 2023-05-15

HD+12, HD+15

Applicant Cardioline S.P.A

K-Number K220526

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LZA 2023-05-15

Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

Applicant Careglove Global Sdn. Bhd.

K-Number K230121

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EOQ 2023-05-15

Vathin® Video Bronchoscope System

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K223836

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OHS 2023-05-14

myLEDmask

Applicant Myblend

K-Number K223147

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NUH 2023-05-13

HEATING TENS/EMS, FT-810R

Applicant Hivox Biotek, Inc.

K-Number K223308

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KGO 2023-05-13

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K230217

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