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

KWQ 2021-03-23

APOLLO Anterior Cervical Plate (ACP) System

Applicant Aurora Spine, Inc.

K-Number K210325

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OUR 2021-03-23

Harvester SI: Sacroiliac Fixation System

Applicant Spinus International, Inc.

K-Number K203780

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IYN 2021-03-23

TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K203391

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FXX 2021-03-23

ICU Health Surgical Mask

Applicant Plastikon Industries

K-Number K203064

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DXQ 2021-03-23

Aneroid Sphygmomanometer

Applicant Wuxi Exanovo Medical Instrument Co., Ltd.

K-Number K203620

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EBI 2021-03-23

DIOnavi-Denture02

Applicant Dio Corporation

K-Number K210828

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LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K203296

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LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K203292

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LJO 2021-03-22

Capture-CMV

Applicant Immucor, Inc.

K-Number K203612

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LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K203289

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FLL 2021-03-22

Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026

Applicant Shenzhen Juzhong Technology Co., Ltd.

K-Number K202009

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FMI 2021-03-22

EZ-IO Intraosseous Vascular Access System

Applicant Teleflex Medical

K-Number K202492

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