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)
Top companies in FOZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | None listed |
| Jan 30, 2008 | AM2 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 |
FOZ | K032417 |
| Mar 16, 2007 | Cook, 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 |
FOZ | K950118 |
| Dec 29, 2006 | Edwards Lifesciences Corporation of Puerto Rico Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S Terminated |
FOZ | K992532 |
| Jun 17, 2006 | United States Surgical Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter
Catalog Number: 120066 Terminated |
FOZ | K902135 |
| Jun 17, 2006 | United States Surgical Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath
Catalog Number: 120049 Terminated |
FOZ | K902135 |
| Jun 17, 2006 | United States Surgical Auto Suture ChemoSite Implantablei Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045 Terminated |
FOZ | K902135 |
| Jun 17, 2006 | United States Surgical Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath
Catalog Number: 120039 Terminated |
FOZ | K902135 |
| Jun 17, 2006 | United States Surgical Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter
Catalog Number: 120025 Terminated |
FOZ | K902135 |
| Jun 17, 2006 | United 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 |
FOZ | K902135 |
| Mar 18, 2005 | Becton Dickinson Infusion Therapy Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray Terminated |
FOZ | K033500 |
| Mar 18, 2005 | Becton Dickinson Infusion Therapy Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray Terminated |
FOZ | K033500 |
| Mar 10, 2005 | Becton Dickinson Infusion Therapy BD Nexiva Closed IV Catheter System, 24 gauge Terminated |
FOZ | K032843 |
| Mar 10, 2005 | Becton Dickinson Infusion Therapy BD Nexiva Closed IV Catheter System, 22 gauge Terminated |
FOZ | K032843 |
| Mar 10, 2005 | Becton Dickinson Infusion Therapy BD Nexiva Closed IV Catheter System, 20 gauge Terminated |
FOZ | K032843 |
| Mar 10, 2005 | Becton Dickinson Infusion Therapy BD Nexiva Closed IV Catheter System, 18 gauge Terminated |
FOZ | K032843 |
| Mar 1, 2005 | IV Flush LLC Sodium Chloride Injection USP, manufactured by IV Flush LLC Terminated |
FOZ | None listed |
| Mar 1, 2005 | IV Flush LLC Heparin Lock Flush Solution, manufactured by IV Flush LLC Terminated |
FOZ | None listed |
| Oct 28, 2004 | Arrow 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 |
FOZ | K993691 |
| Jul 20, 2004 | Braun,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 |
FOZ | K020785 K982805 |
| Jul 20, 2004 | Becton Dickinson Infusion Therapy BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. Terminated |
FOZ | K974764 |
| Jul 20, 2004 | Becton Dickinson Infusion Therapy BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. Terminated |
FOZ | K974764 |
| Feb 24, 2004 | Abbott Laboratories HPD/ADD/GPRD 18 Gauge thin wall needle as part of a Central Venous Catheter Kit Terminated |
FOZ | K961552 |
| Dec 24, 2003 | Edwards 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 |
FOZ | K992532 |
| Nov 27, 2003 | Vygon US LLC Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle. Terminated |
FOZ | K853370 |
| Nov 27, 2003 | Vygon US LLC Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. Terminated |
FOZ | K853370 |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107 Terminated |
FOZ | K904334 |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106 Terminated |
FOZ | K904334 |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105 Terminated |
FOZ | K904334 |
| Jan 23, 2003 | Baxter Healthcare Corp. 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case Terminated |
FOZ | K003245 |
| Jan 23, 2003 | Baxter 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 |
FOZ | K003245 |
| Jan 23, 2003 | Baxter Healthcare Corp. 0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case Terminated |
FOZ | K984590 |
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