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

FIP 2021-10-19

U9000 Plus Ultrafilter

Applicant Baxter Healthcare Corporation

K-Number K211035

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LZA 2021-10-19

Nitrile Examination Gloves

Applicant Niujian Technology Co., Ltd.

K-Number K210706

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DXT 2021-10-19

Sterile High-pressure Angiographic Syringes for Single-use

Applicant Shenzhen Boon Medical Supply Co., Ltd.

K-Number K211564

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HGX 2021-10-19

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

Applicant Uzinmedicare Co.

K-Number K210124

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MWI 2021-10-19

Capsule Vitals Plus Patient Monitoring System

Applicant Capsule Technologie Sas

K-Number K210204

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FRO 2021-10-19

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)

Applicant Winner Medical Co., Ltd.

K-Number K202982

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GEI 2021-10-19

Single Use Irrigation bipolar cable

Applicant Modern Medical Equipment Manufacturing, Ltd.

K-Number K211170

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QEW 2021-10-19

WOLF Thrombectomy System, 14F

Applicant Devoro Medical, Inc.

K-Number K210911

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DXQ 2021-10-19

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

Applicant Shanghai Caremate Medical Device Co., Ltd.

K-Number K211084

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GEX 2021-10-19

AcuPulse CO2 Laser System, Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K212703

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OAS 2021-10-19

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

Applicant Hdx Will Corp.

K-Number K212254

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IPF 2021-10-19

MyoWorx TM20

Applicant Myoworx, Inc.

K-Number K192746

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