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Cordis Corporation

131 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785M recall (Z-2428-2021)Cordis Corporation2021-09-15
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB recall (Z-2429-2021)Cordis Corporation2021-09-15
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A recall (Z-2430-2021)Cordis Corporation2021-09-15
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B recall (Z-2431-2021)Cordis Corporation2021-09-15
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C recall (Z-2432-2021)Cordis Corporation2021-09-15
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S recall (Z-1477-2020)Cordis Corporation2020-02-28
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath I recall (Z-1174-2016)Cordis Corporation2016-03-15
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) recall (Z-2405-2015)Cordis Corporation2015-08-18
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral recall (Z-0998-2015)Cordis Corporation2015-01-16
Cordis EMPIRA NC RX PTCA Dilatation Catheter recall (Z-2556-2014)Cordis Corporation2014-08-28
Cordis EMPIRA RX PTCA Dilatation Catheter recall (Z-2557-2014)Cordis Corporation2014-08-28
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. recall (Z-1784-2014)Cordis Corporation2014-06-11
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmon recall (Z-0081-2014)Cordis Corporation2013-10-25
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interve recall (Z-0003-2014)Cordis Corporation2013-10-01
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466 recall (Z-1887-2013)Cordis Corporation2013-08-07
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SE recall (Z-1507-2013)Cordis Corporation2013-06-06
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Fe recall (Z-1508-2013)Cordis Corporation2013-06-06
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SE recall (Z-1509-2013)Cordis Corporation2013-06-06
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Fe recall (Z-1510-2013)Cordis Corporation2013-06-06
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Fe recall (Z-1511-2013)Cordis Corporation2013-06-06
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX5 recall (Z-0740-2013)Cordis Corporation2013-01-25
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm*** recall (Z-2441-2012)Cordis Corporation2012-09-21
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm recall (Z-2442-2012)Cordis Corporation2012-09-21
Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Ca recall (Z-1507-2012)Cordis Corporation2012-05-10
Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF recall (Z-1508-2012)Cordis Corporation2012-05-10
S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is recall (Z-1039-2012)Cordis Corporation2012-02-15
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by recall (Z-1040-2012)Cordis Corporation2012-02-15
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 c recall (Z-0204-2012)Cordis Corporation2011-11-17
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 c recall (Z-0205-2012)Cordis Corporation2011-11-17
Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. recall (Z-1421-2010)Cordis Corporation2010-04-20
Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3 recall (Z-0623-2010)Cordis Corporation2010-01-13
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Gre recall (Z-0087-2010)Cordis Corporation2009-11-05
MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to b recall (Z-0604-2009)Cordis Corporation2008-12-30
Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry recall (Z-0279-2009)Cordis Corporation2008-10-31
CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in recall (Z-1556-2008)Cordis Corporation2008-07-31
CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Distributed by Cordi recall (Z-0747-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250, Distributed by Cordi recall (Z-0748-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.75 x 10 Dilatation Catheter, Catalog # :70110275, Distributed by Cord recall (Z-0749-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.00 x 10 Dilatation Catheter, Catalog # 70110300, Distributed by Cordi recall (Z-0750-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.25 x 10 Dilatation Catheter, Catalog # 70110325, Distributed by Cordi recall (Z-0751-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Distributed by Cordi recall (Z-0752-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.75 x 10 Dilatation Catheter, Catalog # 70110375, Distributed by Cordi recall (Z-0753-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 4.00 x 10 Dilatation Catheter, Catalog # 70110400, Distributed by Cordi recall (Z-0754-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.25 x 15 Dilatation Catheter, Catalog # 70115225, Distributed by Cordi recall (Z-0755-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250, Distributed by Cordi recall (Z-0756-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Distributed by Cordi recall (Z-0757-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300, Distributed by Cordi recall (Z-0758-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325, Distributed by Cordi recall (Z-0759-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350, Distributed by Cordi recall (Z-0760-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.75 x 15 Dilatation Catheter, Catalog # 70115375, Distributed by Cordi recall (Z-0761-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400, Distributed by Cordi recall (Z-0762-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.25 x 20 Dilatation Catheter, Catalog # 70120225, Distributed by Cordi recall (Z-0763-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.50 x 20 Dilatation Catheter, Catalog # 70120250, Distributed by Cordi recall (Z-0764-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.75 x 20 Dilatation Catheter, Catalog # 70120275, Distributed by Cordi recall (Z-0765-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.00 x 20 Dilatation Catheter, Catalog # 70120300, Distributed by Cordi recall (Z-0766-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.25 x 20 Dilatation Catheter, Catalog # 70120325, Distributed by Cordi recall (Z-0767-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.50 x 20 Dilatation Catheter, Catalog # 70120350, Distributed by Cordi recall (Z-0768-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.75 x 20 Dilatation Catheter, Catalog # 70120375, Distributed by Cordi recall (Z-0769-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 4.00 x 20 Dilatation Catheter, Catalog # 70120400, Distributed by Cordi recall (Z-0770-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Distributed by Cordi recall (Z-0771-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.50 x 25 Dilatation Catheter, Catalog # 70125250, Distributed by Cordi recall (Z-0772-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275, Distributed by Cordi recall (Z-0773-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.00 x 25 Dilatation Catheter, Catalog # 70125300, Distributed by Cordi recall (Z-0774-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.25 x 25 Dilatation Catheter, Catalog # 70125325, Distributed by Cordi recall (Z-0775-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.50 x 25 Dilatation Catheter, Catalog # 70125350, Distributed by Cordi recall (Z-0776-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375, Distributed by Cordi recall (Z-0777-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 4.00 x 25 Dilatation Catheter, Catalog # 70125400, Distributed by Cordi recall (Z-0778-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.25 x 30 Dilatation Catheter, Catalog # 70130225, Distributed by Cordi recall (Z-0779-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.50 x 30 Dilatation Catheter, Catalog # 70130250, Distributed by Cordi recall (Z-0780-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 2.75 x 30 Dilatation Catheter, Catalog # 70130275, Distributed by Cordi recall (Z-0781-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.00 x 30 Dilatation Catheter, Catalog # 70130300, Distributed by Cordi recall (Z-0782-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.25 x 30 Dilatation Catheter, Catalog # 70130325, Distributed by Cordi recall (Z-0783-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.50 x 30 Dilatation Catheter, Catalog # 70130350, Distributed by Cordi recall (Z-0784-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 3.75 x 30 Dilatation Catheter, Catalog # 70130375, Distributed by Cordi recall (Z-0785-2008)Cordis Corporation2008-02-06
CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400, Distributed by Cordi recall (Z-0786-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Di recall (Z-0787-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011015S, recall (Z-0788-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, D recall (Z-0789-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011020S, recall (Z-0790-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordi recall (Z-0791-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250, Distributed by Cordi recall (Z-0792-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.75 x 10 Dilatation Catheter, Catalog # 80110275, Distributed by Cordi recall (Z-0793-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, Distributed by Cordi recall (Z-0794-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.25 x 10 Dilatation Catheter, Catalog # 80110325, Distributed by Cordi recall (Z-0795-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Distributed by Cordi recall (Z-0796-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011515D,Di recall (Z-0797-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011515S, recall (Z-0798-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, D recall (Z-0799-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S, recall (Z-0800-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225, Distributed by Cordi recall (Z-0801-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, Distributed by Cordi recall (Z-0802-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.75 x 15 Dilatation Catheter, Catalog # 80115275, Distributed by Cordi recall (Z-0803-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordi recall (Z-0804-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.25 x 15 Dilatation Catheter, Catalog # 80115325, Distributed by Cordi recall (Z-0805-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350, Distributed by Cordi recall (Z-0806-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 20, Dual Marker Band , Dilatation Catheter, Catalog # 8012015D, recall (Z-0807-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, recall (Z-0808-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, D recall (Z-0809-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.00 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012020S, recall (Z-0810-2008)Cordis Corporation2008-02-06
CORDIS "Fire Star" 2.25 x 20 Dilatation Catheter, Catalog # 80120225, Distributed by Cordi recall (Z-0811-2008)Cordis Corporation2008-02-06
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