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

GEH 2018-07-30

IceSphere 1.5 CX Cryoablation Needle

Applicant Galil Medical , Ltd.

K-Number K181741

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FTC 2018-07-30

308nm Excimer System

Applicant Chongqing Peninsula Medical Technology Co., Ltd.

K-Number K172273

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DQK 2018-07-30

Epiphany Cardio Server Mobile

Applicant Epiphany Healthcare, LLC

K-Number K181720

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GEX 2018-07-30

Laser Ureteral Catheter

Applicant Cook Incorporated

K-Number K181431

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NKG 2018-07-30

Proficient® Posterior Cervical Spine System

Applicant Spine Wave, Inc.

K-Number K181440

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LFZ 2018-07-30

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K181213

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GXN 2018-07-27

OsteoFab Patient Specific Cranial Device

Applicant Oxford Performance Materials, Inc.

K-Number K180064

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HSB 2018-07-27

OIC Intramedullary Nail System

Applicant The Orthopaedic Implant Company

K-Number K181184

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LFD 2018-07-27

Voutia

Applicant Jeffrey Ward Cash, Dds

K-Number K173808

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KTB 2018-07-27

Macroduct Advanced Model 3710

Applicant Elitechgroup, Inc.

K-Number K180627

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NJR 2018-07-27

Panther Fusion GBS Assay

Applicant Diagenode

K-Number K181156

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FJS 2018-07-27

Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Applicant Covidien, LLC

K-Number K180485

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