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

HWC 2019-03-13

Wright Jones Fracture System

Applicant Wrightmedicaltechnologyinc

K-Number K183026

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MQB 2019-03-13

BIOK7600W Wireless Flat Panel Detector

Applicant Biokinemetrics, Inc.

K-Number K190300

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MAX 2019-03-13

MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF)

Applicant MiRus, LLC

K-Number K182920

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MQN 2019-03-13

DePuy Synthes Maxillofacial Portfolio - MR Conditional

Applicant Synthes (USA) Products, LLC

K-Number K183113

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MSX 2019-03-13

BeneVision Central Monitoring System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K183238

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FTM 2019-03-13

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional

Applicant Synthes (USA) Products, LLC

K-Number K183472

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PGY 2019-03-13

JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K183492

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GDW 2019-03-13

FasTouch Absorbable Fixation System

Applicant Via Surgical , Ltd.

K-Number K181668

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NKB 2019-03-13

Modular Spinal Fixation System

Applicant Life Spine, Inc.

K-Number K183430

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KXK 2019-03-13

GammaTile

Applicant Gt Medical Technologies

K-Number K190296

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LPH 2019-03-13

Alteon Acetabular Cup System

Applicant Exactech, Inc.

K-Number K182502

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NKB 2019-03-12

ISS-JAZZ Screw System and JAZZ CAP SP

Applicant Implanet, S.A.

K-Number K182771

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