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

FXX 2022-01-28

Surgical Masks

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K212120

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GEI 2022-01-28

ShinEvac Smoke Evacuation Pencil

Applicant Shining World Health Care Co., Ltd.

K-Number K213317

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IYN 2022-01-28

X-CUBE i8, X-CUBE i9

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K213523

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BTT 2022-01-28

Optiflow Oxygen Kit

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K211096

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GXQ 2022-01-28

SyntheCel Dura Repair

Applicant Synthes (USA) Products, LLC

K-Number K212943

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FLL 2022-01-28

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K213082

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QAS 2022-01-28

syngo.CT Brain Hemorrhage

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203260

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KLE 2022-01-28

STEP-1 PumEtch

Applicant Rounding Third, LLC

K-Number K213093

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LZC 2022-01-28

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

Applicant Anhui Xinyisheng Medical Technology Co.,Ltd

K-Number K213325

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GEX 2022-01-28

Platform treatment system

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K203395

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DQY 2022-01-28

QuikPass Catheter

Applicant Traverse Vascular, Inc.

K-Number K214106

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JHX 2022-01-28

VITROS Immunodiagnostic Products CK-MB Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K212648

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