ClearanceBrief
Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

9510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
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Top companies in FOZ

Decided510(k)Device and applicantCode
Apr 23, 2020K192230MF SAFECATH
Medifirst Co., Ltd., KR
FOZ
Apr 7, 2020K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)
Bard Access Systems, Inc. (Bard Has Joined Bd)
FOZ
Apr 1, 2020K192676Introcan Safety 2 IV Catheter 18-24 gauge
B.Braun Medical, Inc.
FOZ
Mar 12, 2020K200263Health Line CT Midline Catheter
Health Line International Corporation
FOZ
Jan 24, 2020K192493BD Cathena (TM) Safety IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Dec 10, 2019K192533Health Line CT CVC
Health Line International Corporation
FOZ
Nov 1, 2019K190855BD Acute Central Line
Bard Access Systems, Inc. (Bard Has Joined Bd)
FOZ
Sep 20, 2019K190001Supercath 5
Togo Medikit Co., Ltd., JP
FOZ
Sep 18, 2019K191232AccuCath Ace Intravascular Catheter
C.R. Bard, Inc.
FOZ
May 17, 2019K182252Cook Unimpregnated Central Venous Catheter
Cook Incorporated
FOZ
Mar 20, 2019K183399BD Nexiva Closed IV Catheter System
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Mar 7, 2019K182870Introcan Safety 3 Closed IV Catheter
B.Braun Medical, Inc.
FOZ
Jan 16, 2019K182538Merit RadialFlo Arterial Catheter
Merit Medical Singapore Pte. , Ltd., SG
FOZ
Mar 23, 2018K172496SUPERCATH 5 (26G)
Togo Medikit Co., Ltd., JP
FOZ
Dec 21, 2017K171530Deltaven XiV Max, Deltaven XiV Max FF
Delta Med Spa, IT
FOZ
Dec 15, 2017K173354BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Sep 17, 2017K172506BD Cathena Safety IV Catheter
Becton, Dickinson and Company
FOZ
Aug 17, 2017K172204BD Intima II PLUS Closed IV Catheter System
Becton, Dickinson and Company
FOZ
Apr 28, 2017K163358Introcan Safety 3 Closed IV Catheter
B.Braun Melsungen AG, DE
FOZ
Mar 10, 2017K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
Becton, Dickinson and Company
FOZ
Mar 8, 2017K161681Nipro SafeTouch IV Catheter
Nipro Medical Corporation
FOZ
Feb 28, 2017K170283BD Nexiva Diffusics Closed IV Catheter System
Becton, Dickinson and Company
FOZ
Feb 24, 2017K163513Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
FOZ
Nov 15, 2016K162894AccuCath Intravascular Catheter
C.R. Bard, Inc.
FOZ
Nov 3, 2016K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
Medsource International, LLC
FOZ
Sep 22, 2016K162377PowerGlide Pro Midline Catheter
C.R. Bard, Inc.
FOZ
Sep 8, 2016K161866BioFlo Midline Catheter
Navilyst Medical, Inc.
FOZ
Aug 29, 2016K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Aug 12, 2016K160592SUPERCATH 6
Togo Medikit Co., Ltd., JP
FOZ
Jun 30, 2016K160235ViaValve Safety I.V. Catheter
Smiths Medical Asd, Inc.
FOZ
Jun 2, 2016K153280PowerGlide Pro Midline Catheter
C.R. Bard, Inc.
FOZ
Mar 11, 2016K16037420G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
Tangent Medical Technologies, Inc.
FOZ
Dec 10, 2015K153298AccuCath Intravascular Catheter
C.R. Bard, Inc.
FOZ
Nov 23, 2015K152272Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
FOZ
Jul 27, 2015K151698BD Angiocath IV Catheter, BD Insyte IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jul 15, 2015K150611MedSource ClearSafe Safety IV Catheter
Medsource International
FOZ
Jul 8, 2015K151513Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)
FOZ
Jun 18, 2015K142797I.V. Catheter
Jiangxi Sanxin Medtec Co., Ltd., CN
FOZ
Jun 5, 2015K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
Arrow International (A Subsidiary of Teleflex, Inc.)
FOZ
May 15, 2015K150407BioFlo Midline Catheter
Navilyst Medical, Inc.
FOZ
Apr 9, 2015K143610BD INTIMA II CLOSED IV CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jan 8, 2015K142136ACCUCATH MIDLINE CATHETER SYSTEM
Vascular Pathways, Inc.
FOZ
Aug 20, 2014K140270NEXUS MIDLINE CT CATHETER
Health Line International Corporation
FOZ
Jul 30, 2014K141026LEADERFLEX
Vygon
FOZ
Jul 17, 2014K140504ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
Vascular Pathways, Inc.
FOZ
Jun 12, 2014K133280TERUMO SURFLO I.V. CATHETER
Terumo (Philippines) Corporation
FOZ
May 30, 2014K141138SURFLASH SAFETY I.V. CATHETER
Kofu Factory of Terumo Corp.
FOZ
May 12, 2014K140419SUPERCATH5
Togo Medikit Co., Ltd., JP
FOZ
Feb 14, 2014K140136NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
Nipro Medical Corporation
FOZ
Jan 31, 2014K131555MEDSOURCE IV SAFETY CATHETER
Medsource International, LLC
FOZ

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