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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2014 | K133856 | POWERGLIDE MIDLINE CATHETER C.R. Bard, Inc. | FOZ |
| Dec 5, 2013 | K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER Nipro Medical Corporation | FOZ |
| Apr 30, 2013 | K130518 | MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER Luther Needlesafe Products, Inc. | FOZ |
| Mar 5, 2013 | K121488 | JMS SAFE WING CATH (SWC) JMS North America Corporation | FOZ |
| Jan 17, 2013 | K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Dec 28, 2012 | K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 Delta Med Srl | FOZ |
| Nov 2, 2012 | K123267 | SURFFLASH(R) PLUS SAFETY I.V. CATHETER Kofu Factory of Terumo Corp. | FOZ |
| Sep 5, 2012 | K122544 | TERUMO SURFLASH SAFETY I.V. CATHETER Terumo Corporation, JP | FOZ |
| Jul 20, 2012 | K120839 | NOVACATH SECURE IV CATHETER SYSTEM-18G Tangent Medical Technologies, Inc. | FOZ |
| Jul 11, 2012 | K111939 | M/29TM - PRESSURE INJECTABLE Flexicath , Ltd., IL | FOZ |
| Jun 1, 2012 | K121073 | POWERGLIDE MIDLINE CATHETER C.R. Bard, Inc. | FOZ |
| May 18, 2012 | K113622 | ORION II CT CVC Health Line International Corporation (Hlic) | FOZ |
| May 18, 2012 | K113565 | MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN Edwards Lifesciences, LLC | FOZ |
| Apr 16, 2012 | K112290 | SUPERCATH Z3V Togo Medikit Co., Ltd., JP | FOZ |
| Mar 14, 2012 | K113700 | VIAVALVE SAFETY IV CATHETER Smiths Medical Asd, Inc. | FOZ |
| Mar 12, 2012 | K113429 | SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER Nipro Medical Corporation | FOZ |
| Feb 16, 2012 | K120337 | I-PORT ADVANCE INJECTION PORT Unomedical A/S, DK | FOZ |
| Feb 8, 2012 | K112542 | YOMURA SAFETY I.V. CATHETER Yomura Technologies, Inc., TW | FOZ |
| Dec 21, 2011 | K110794 | AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS Ameco Medical Industries | FOZ |
| Sep 30, 2011 | K111366 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM Becton, Dickinson and Company (BD) | FOZ |
| Sep 22, 2011 | K112347 | RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE Vascular Pathways, Inc. | FOZ |
| Aug 30, 2011 | K111236 | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 B.Braun Melsungen AG | FOZ |
| Jul 19, 2011 | K110443 | BD INSYTE AUTOGUARD BC Becton, Dickinson & CO | FOZ |
| Jan 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jun 3, 2010 | K100775 | BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| May 6, 2010 | K100974 | SPECTRUM TURBO-JECT PICC SET Cook Incorporated | FOZ |
| Feb 26, 2010 | K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Terumo Corp. | FOZ |
| Dec 17, 2009 | K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX Togo Medikit Co., Ltd., JP | FOZ |
| Oct 13, 2009 | K091709 | MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC Edwards Lifesciences, LLC | FOZ |
| Sep 25, 2009 | K092629 | SNM FIRMGRIP Flexicath , Ltd., IL | FOZ |
| Aug 7, 2009 | K083429 | I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT Weihai Jierui Medical Products Co., Ltd., CN | FOZ |
| May 1, 2009 | K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) Terumo Corp. | FOZ |
| Apr 15, 2009 | K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER Terumo Medical Corp. | FOZ |
| Mar 12, 2009 | K081953 | SUPERCATH 5 Togo Medikit Co., Ltd., JP | FOZ |
| Mar 10, 2009 | K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET U.S. Safety Syringes Co., Inc. | FOZ |
| Feb 5, 2009 | K090122 | NUOVOGUARD U.S. Safety Syringes Co., Inc. | FOZ |
| Dec 4, 2008 | K083454 | NUOVOCATH U.S. Safety Syringes Co., Inc. | FOZ |
| Nov 7, 2008 | K081420 | VANISHPOINT I.V. CATHETER Retractable Technologies, Inc. | FOZ |
| Oct 16, 2008 | K080793 | FIRMGRIP Flexicath , Ltd., IL | FOZ |
| Sep 17, 2008 | K082362 | SURSHIELD SAFETY I.V. CATHETER Terumo Medical Corp. | FOZ |
| Jul 30, 2008 | K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS Cook, Inc. | FOZ |
| Jul 14, 2008 | K081690 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER Cook, Inc. | FOZ |
| Apr 30, 2008 | K073471 | VANTAGECATH INTRAVASCULAR CATHETER Advantage Medical Device | FOZ |
| Apr 11, 2008 | K073520 | ANGIOTECH CVC Angiotech Pharmaceuticals, Inc. | FOZ |
| Feb 8, 2008 | K073241 | VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM Vascular Pathways | FOZ |
| Nov 30, 2007 | K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 Vygon Corp. | FOZ |
| Nov 9, 2007 | K072419 | ADVANTIV SAFETY I.V. CATHETER Smiths Medical Asd, Inc. | FOZ |
| Oct 16, 2007 | K071382 | SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, Shinchang Medical Co., Ltd. | FOZ |
| Aug 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc. | FOZ |
| Aug 16, 2007 | K070020 | COMCASET-P SAFETY IV CATHETER Pitango Medical, Ltd., IL | FOZ |
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