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

PRB 2021-12-10

CINtec Histology

Applicant Ventana Medical Systems, Inc.

K-Number K212176

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FTC 2021-12-10

i8 Tanning Booth

Applicant Ultrasun International B.V.

K-Number K210004

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MSX 2021-12-09

AirStrip ONE Web Client with Alarm Communication Management (ACM)

Applicant Airstrip Technologies, Inc.

K-Number K211949

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QIH 2021-12-09

LVivo Seamless

Applicant Dia Imaging Analysis, Ltd.

K-Number K212466

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HWC 2021-12-09

Nextra CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K-Number K213530

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JWH 2021-12-09

LOSPA TKR System

Applicant Corentec Co., Ltd.

K-Number K212034

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GEI 2021-12-09

Plasma IQ

Applicant Neauvia North America, Inc.

K-Number K212329

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MHX 2021-12-09

Infinity Acute Care System (IACS) Monitoring Solution

Applicant Draeger Medical Systems, Inc.

K-Number K201764

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OVE 2021-12-09

SeaSpine WaveForm, C Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K213359

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LZA 2021-12-09

Disposable Medical Nitrile Examination Gloves (Model:XYS-001)

Applicant Anhui Xinyisheng Medical Technology Co.,Ltd

K-Number K213371

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MVL 2021-12-09

VOCO Retraction Paste

Applicant Voco GmbH

K-Number K213149

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MAX 2021-12-08

ShurFit Lumbar Interbody System

Applicant Precision Spine, Inc.

K-Number K212075

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