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

JWH 2021-04-21

U2 Total Knee System, XPE Tibial Insert, PS PLUS

Applicant United Orthopedic Corporation

K-Number K210961

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LZA 2021-04-21

Nitrile Glove Powder Free Blue

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K210145

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SBF 2021-04-21

Knee+

Applicant Pixee Medical

K-Number K202750

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JWH 2021-04-21

MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K-Number K210483

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MQB 2021-04-21

Yushan X-Ray Flat Panel Detector with DROC

Applicant Innocare Optoelectronics Corp.

K-Number K210988

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CBK 2021-04-20

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

Applicant Maquet Critical Care AB

K-Number K201874

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HRS 2021-04-20

SOLE Medial Column Fusion Plate

Applicant Orthofix Srl

K-Number K210157

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NOY 2021-04-20

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

Applicant Biocompatibles UK Ltd (Part of Boston Scientific Corporation

K-Number K203276

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LCM 2021-04-20

SEFRIA PCP Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K-Number K203489

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MQC 2021-04-20

Panthera Occlusal Appliance

Applicant Panthera Dental, Inc.

K-Number K203596

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IYE 2021-04-20

Identify

Applicant Varian Medical Systems, Inc.

K-Number K210835

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PDU 2021-04-20

SoundBite Crossing System - Peripheral (14P)

Applicant Soundbite Medical Solutions, Inc.

K-Number K210839

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