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

JXG 2017-10-16

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag

Applicant Codman & Shurtleff, Inc.

K-Number K172537

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MBI 2017-10-16

BioWick X Implant with Driver

Applicant Cayenne Medical, Inc.

K-Number K172186

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DQK 2017-10-16

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K170948

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MTD 2017-10-16

AcQMap 3D Imaging and Mapping Catheter

Applicant Acutus Medical, Inc.

K-Number K170819

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GEI 2017-10-13

CELFIRM

Applicant VIOL Co., Ltd.

K-Number K172023

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MQB 2017-10-13

DX-D Imaging Package

Applicant Agfa Healthcare N.V.

K-Number K172784

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FRG 2017-10-13

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

Applicant Pms Tibbi Cihazlar Teknolojisi San VE Tic AS

K-Number K162362

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FTC 2017-10-13

Exciplex308nm

Applicant Clarteis

K-Number K171702

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DXN 2017-10-13

Electronic Blood Pressure Monitor

Applicant Shenzhen Pango Electronic Co., Ltd.

K-Number K170151

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BSJ 2017-10-13

SuperNO2VA Device

Applicant Revolutionary Medical Devices, Inc.

K-Number K163277

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JLW 2017-10-13

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

Applicant Boditech Med, Inc.

K-Number K170232

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HSB 2017-10-13

NOVOS-NAIL Limb Lengthening System (LLS)

Applicant Smith & Nephew

K-Number K163653

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