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

LZA 2021-11-01

Nitrile Examination Gloves (Blue, Violet)

Applicant Lyncmed Medical Technology (Beijing) Co., Ltd.

K-Number K211586

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LZA 2021-10-31

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210588

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JCT 2021-10-30

Tracheal Stent System (Y-Shaped)

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K212403

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FLE 2021-10-29

Enbio S

Applicant Enbio Group AG

K-Number K210279

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MAX 2021-10-29

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

Applicant Intelivation, LLC

K-Number K212389

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OWB 2021-10-29

nView s1 with nav option

Applicant Nview Medical

K-Number K211064

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DQK 2021-10-29

CARTO 3 EP Navigation System Version 7.2

Applicant Biosense Webster, Inc.

K-Number K213264

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FDA 2021-10-29

Balloon BS-3

Applicant Fujifilm Corporation

K-Number K213195

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MOS 2021-10-29

ds Head 32ch 3.0T

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K213351

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FLL 2021-10-29

Phoenix Digital Thermometer

Applicant Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

K-Number K201032

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DFH 2021-10-29

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K201496

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MAX 2021-10-29

MectaLIF Extension

Applicant Medacta International S.A.

K-Number K212831

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