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

PPN 2018-06-27

Shockwave Medical Intravascular Lithotripsy (IVL) System

Applicant Shockwave Medical, Inc.

K-Number K180454

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FMI 2018-06-27

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

Applicant Medibio USA, LLC

K-Number K180720

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OCW 2018-06-27

OverStitch Endoscopic Suturing System and Accessories

Applicant Apollo Endosurgery

K-Number K181141

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KPR 2018-06-27

uDR 592h, uDR 596i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181413

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ODP 2018-06-27

HD LifeSciences Cervical IBFD System

Applicant Hd Lifesciences, LLC

K-Number K180364

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DFH 2018-06-26

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K-Number K181438

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NJR 2018-06-26

NeuMoDx GBS Assay

Applicant Neumodx Molecular, Inc.

K-Number K173725

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LKF 2018-06-26

Uterine Manipulator

Applicant Beijing Hangtian Kadi Technology R&D Institute

K-Number K172846

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OKC 2018-06-26

SecurAcath

Applicant Interrad Medical, Inc.

K-Number K180769

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FPA 2018-06-26

IV Administration Set

Applicant B.Braun Medical, Inc.

K-Number K173361

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NKB 2018-06-26

Range (Denali and Mesa) Spinal Systems

Applicant K2m, Inc.

K-Number K181119

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LLZ 2018-06-26

DenSeeMammo

Applicant Statlife

K-Number K173574

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