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

LHN 2019-09-27

Radiance 330 Proton Beam Therapy System

Applicant Protom International Holding Corporation

K-Number K191521

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MQV 2019-09-27

Sorrento Bone Graft Substitute

Applicant Xenco Medical, LLC

K-Number K191074

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LPL 2019-09-27

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

Applicant Clearlab SG Pte, Ltd.

K-Number K192129

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OMP 2019-09-27

XLR8 Abdominal Wound Dressing Kit

Applicant Genadyne Biotechnologies

K-Number K182722

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JWY 2019-09-27

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

Applicant Biomerieux S.A.

K-Number K192050

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FTL 2019-09-27

FlexBand Plus

Applicant International Life Sciences

K-Number K192112

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NDP 2019-09-27

CEREC Guides

Applicant Dentsply Sirona

K-Number K190059

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GCJ 2019-09-26

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar

Applicant Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

K-Number K190029

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LZA 2019-09-26

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

Applicant Shen Wei USA, Inc.

K-Number K190466

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NEU 2019-09-26

BioZorb SP Marker

Applicant Focal Therapeutics

K-Number K192371

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ODP 2019-09-26

eCarbon IBDs

Applicant Back 2 Basics Direct, LLC

K-Number K191537

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DRE 2019-09-26

Sterile Dilator

Applicant Galt Medical Corp.

K-Number K192195

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