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

CAC 2019-09-27

CATSmart

Applicant Fresenius Kabi AG

K-Number K192368

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FMF 2019-09-27

EpiFaith Syringe

Applicant Flat Medical Co., Ltd.

K-Number K192421

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LZO 2019-09-27

MiniMAX

Applicant Medacta International S.A.

K-Number K192352

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DTZ 2019-09-27

Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir

Applicant Medtronic, Inc.

K-Number K191444

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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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