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

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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LLZ 2021-10-29

ATEC Alignment App

Applicant Alphatec Spine, Inc.

K-Number K211987

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FTM 2021-10-29

VersaWrap

Applicant Alafair Biosciences, Inc.

K-Number K213163

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QIH 2021-10-29

Critical Care Suite with Endotracheal Tube Positing AI algorithm

Applicant Ge Medical Systems, LLC

K-Number K211161

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PHU 2021-10-29

TraumaGuard Intra-abdominal Pressure Sensing System

Applicant Sentinel Medical Technologies, LLC

K-Number K210570

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