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

DQY 2021-10-21

XO Cross Support Catheter

Applicant Transit Scientific, LLC

K-Number K210322

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EOQ 2021-10-21

PENTAX Medical Video Bronchoscope EB11-J10

Applicant Pentax of America, Inc.

K-Number K210928

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GEX 2021-10-21

DEKA LipoAI

Applicant El.En Electronic Engineering Spa

K-Number K212270

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NGX 2021-10-21

Legend Pro DMA

Applicant Pollogen, Ltd.

K-Number K200545

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LZA 2021-10-21

Medical Examination Gloves

Applicant Guangzhou Junda Gloves Co., Ltd.

K-Number K212311

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CCK 2021-10-21

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

Applicant GE Healthcare Finland Oy

K-Number K211171

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OXO 2021-10-21

Orthoscan Tau Mini C-Arm

Applicant Orthoscan, Inc.

K-Number K213113

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FDS 2021-10-20

PENTAX Medical Video Upper GI Scopes EG17-J10

Applicant Pentax of America, Inc.

K-Number K210177

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NHA 2021-10-20

Multi-unit Abutment, Multi-unit Angled Abutment

Applicant Megagen Implant Co., Ltd.

K-Number K203808

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JWY 2021-10-20

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

Applicant Liofilchem s.r.l.

K-Number K211672

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MZV 2021-10-20

Piccolo Potassium Test System

Applicant Abaxis, Inc.

K-Number K200865

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QKB 2021-10-20

Contour ProtegeAI

Applicant Mim Software, Inc.

K-Number K210632

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