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

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

Regulation 880.5200

8510(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

DateFirm and productCodeLinked 510(k)
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush,
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02, NDC #64054-3003-02, 3mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flus
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Heparin Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flus
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Normal Saline IV Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathwa
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solutio
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distribute
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distribut
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solut
Terminated
FOZNone listed
Jan 30, 2008AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solut
Terminated
FOZK032417
Mar 16, 2007Cook, Inc.
COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
Terminated
FOZK950118
Dec 29, 2006Edwards Lifesciences Corporation of Puerto Rico
Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Terminated
FOZK992532
Jun 17, 2006United States Surgical
Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120066
Terminated
FOZK902135
Jun 17, 2006United States Surgical
Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049
Terminated
FOZK902135
Jun 17, 2006United States Surgical
Auto Suture ChemoSite Implantablei Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045
Terminated
FOZK902135
Jun 17, 2006United States Surgical
Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039
Terminated
FOZK902135
Jun 17, 2006United States Surgical
Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120025
Terminated
FOZK902135
Jun 17, 2006United States Surgical
Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021
Terminated
FOZK902135
Mar 18, 2005Becton Dickinson Infusion Therapy
Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray
Terminated
FOZK033500
Mar 18, 2005Becton Dickinson Infusion Therapy
Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray
Terminated
FOZK033500
Mar 10, 2005Becton Dickinson Infusion Therapy
BD Nexiva Closed IV Catheter System, 24 gauge
Terminated
FOZK032843
Mar 10, 2005Becton Dickinson Infusion Therapy
BD Nexiva Closed IV Catheter System, 22 gauge
Terminated
FOZK032843
Mar 10, 2005Becton Dickinson Infusion Therapy
BD Nexiva Closed IV Catheter System, 20 gauge
Terminated
FOZK032843
Mar 10, 2005Becton Dickinson Infusion Therapy
BD Nexiva Closed IV Catheter System, 18 gauge
Terminated
FOZK032843
Mar 1, 2005IV Flush LLC
Sodium Chloride Injection USP, manufactured by IV Flush LLC
Terminated
FOZNone listed
Mar 1, 2005IV Flush LLC
Heparin Lock Flush Solution, manufactured by IV Flush LLC
Terminated
FOZNone listed
Oct 28, 2004Arrow International Inc
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+a
Terminated
FOZK993691
Jul 20, 2004Braun,B Medical Inc
Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
Terminated
FOZK020785
K982805
Jul 20, 2004Becton Dickinson Infusion Therapy
BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
Terminated
FOZK974764
Jul 20, 2004Becton Dickinson Infusion Therapy
BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit.
Terminated
FOZK974764
Feb 24, 2004Abbott Laboratories HPD/ADD/GPRD
18 Gauge thin wall needle as part of a Central Venous Catheter Kit
Terminated
FOZK961552
Dec 24, 2003Edwards Lifesciences Corporation of Puerto Rico
Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
Terminated
FOZK992532
Nov 27, 2003Vygon US LLC
Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.
Terminated
FOZK853370
Nov 27, 2003Vygon US LLC
Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
Terminated
FOZK853370
Jul 30, 2003Deltec, Inc
Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107
Terminated
FOZK904334
Jul 30, 2003Deltec, Inc
Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106
Terminated
FOZK904334
Jul 30, 2003Deltec, Inc
Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105
Terminated
FOZK904334
Jan 23, 2003Baxter Healthcare Corp.
100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Terminated
FOZK003245
Jan 23, 2003Baxter Healthcare Corp.
10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Terminated
FOZK003245
Jan 23, 2003Baxter Healthcare Corp.
0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Terminated
FOZK984590

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