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

GWM 2021-04-30

CereLink ICP Monitor

Applicant Integra Lifesciences Production Corporation

K-Number K210993

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DWJ 2021-04-29

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

Applicant 3M Company

K-Number K210605

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FLL 2021-04-29

Infrared Thermometer

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K203454

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MAX 2021-04-29

Expandable Titanium PLIF/TLIF System

Applicant Spectrum Spine, LLC

K-Number K201024

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FXX 2021-04-29

M1 Surgical Face Mask

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K202457

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LOX 2021-04-29

KardiFlex PTCA Balloon Dilatation Catheter

Applicant Medcaptain Life Science Co., Ltd.

K-Number K202619

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LZA 2021-04-29

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

Applicant Harbour Health, LLC

K-Number K210944

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FDF 2021-04-29

Pure Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K210981

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EOQ 2021-04-29

Rescue Pulmonary Grasping Forceps

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K202987

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MQB 2021-04-28

1717FCC

Applicant Rayence Co., Ltd.

K-Number K210985

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DXN 2021-04-28

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor

Applicant Contec Medical Systems Co.,Ltd

K-Number K202757

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LZA 2021-04-28

Disposable Nitrile Examination Gloves

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K203436

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