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

CGR 2021-01-15

IMMULITE® 2000 Cortisol

Applicant Siemens Healthcare Diagnostics Products, Ltd.

K-Number K202826

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LLZ 2021-01-15

AccuBrain

Applicant Brainnow Medical Technology Limited

K-Number K202847

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CGR 2021-01-15

IMMULITE/IMMULITE® 1000 Cortisol

Applicant Siemens Healthcare Diagnostics Products, Ltd.

K-Number K203270

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BYI 2021-01-15

AirPhysio Positive Expiratory Pressure (PEP) Device

Applicant Airphysio Pty, Ltd.

K-Number K203209

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QFM 2021-01-15

uAI EasyTriage-Rib

Applicant Shanghai United Imaging Intelligence Co., Ltd.

K-Number K193271

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FLL 2021-01-15

Non-contact Electronic Forehead Infrared Thermometer

Applicant Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

K-Number K201582

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FLL 2021-01-15

Infrared Thermometer

Applicant Shenzhen Xunwei Industrial Co., Ltd.

K-Number K201579

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LLZ 2021-01-15

ViewPoint 6

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K203677

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MAX 2021-01-15

Ali Interbody Fusion System

Applicant Raed M. Ali, M.D., Inc.

K-Number K203308

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FGB 2021-01-15

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525

Applicant Richard Wolf Medical Instruments Corporation

K-Number K201897

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HWC 2021-01-15

Dynanail Mini Hybrid

Applicant MedShape, Inc.

K-Number K203381

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FXX 2021-01-15

Medical Protective Mask

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K202107

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