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

GEH 2023-05-30

Hydrozid Precise

Applicant Bibawo Medical A/S

K-Number K221897

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FCG 2023-05-30

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

Applicant Cook Ireland, Ltd.

K-Number K230909

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QEW 2023-05-30

Excipio SV Aspiration Catheter and Tubing

Applicant Contego Medical, Inc.

K-Number K230030

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LZA 2023-05-30

First Glove Blue Nitrile Examination Gloves Powder Free

Applicant First Glove Sdn. Bhd.

K-Number K230958

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PBF 2023-05-30

MyPAO Guides

Applicant Medacta International S.A.

K-Number K220706

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FMT 2023-05-30

Babyroo TN300

Applicant Draeger Medical Systems, Inc.

K-Number K230278

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GEI 2023-05-30

Victan

Applicant Jiangsu Haize Medical Scientific Development Co., Ltd.

K-Number K230593

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LLZ 2023-05-30

KBA3D

Applicant S.M.A.I.O

K-Number K223841

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LZA 2023-05-28

Blue Nitrile Examination Gloves Powder Free

Applicant Latrile Gloves Private Limited

K-Number K230601

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OHT 2023-05-26

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

Applicant Shenzhen Ionka Medical Technology Co., Ltd.

K-Number K230739

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DQD 2023-05-26

CORE 500 Digital Stethoscope

Applicant Eko Devices, Inc.

K-Number K230111

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GEX 2023-05-26

Diode Laser System

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K230580

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