Cordis US Corp.
Miami Lakes, FL, US
Cordis US Corp. appears in FDA device records in Miami Lakes, FL. FDA records list 332 510(k) clearances between and , 553 PMA records and 3 registered establishments. As of , FDA records show 170 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Cordis US Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- AccessClosure, Inc., A Cardinal Health Companyenforcement report, recall
- Cordis Corporation510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 332FDA records hold 332 510(k) clearances for Cordis US Corp. between 1976 and 2024. The busiest year on record is 1981, with 23. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 7 |
| 1978 | 7 |
| 1979 | 17 |
| 1980 | 16 |
| 1981 | 23 |
| 1982 | 5 |
| 1983 | 8 |
| 1984 | 5 |
| 1985 | 23 |
| 1986 | 22 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 18 |
| 1992 | 12 |
| 1993 | 11 |
| 1994 | 10 |
| 1995 | 12 |
| 1996 | 15 |
| 1997 | 21 |
| 1998 | 10 |
| 1999 | 14 |
| 2000 | 15 |
| 2001 | 8 |
| 2002 | 9 |
| 2003 | 6 |
| 2004 | 4 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2018 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233637 | Cordis BRITECROSS Support Catheter | DQY | Substantially Equivalent | |
| K232573 | INFINITI™ Ambi Angiographic Catheter | DQO | Substantially Equivalent | |
| K230704 | RAIN Sheath™ Tibial Pedal Introducer | DYB | Substantially Equivalent | |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | LIT | Substantially Equivalent | |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | NTE | Substantially Equivalent | |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | DQO | Substantially Equivalent | |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | LIT | Substantially Equivalent | |
| K202167 | Brite Tip Radianz Guiding Sheath | DYB | Substantially Equivalent | |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | LIT | Substantially Equivalent | |
| K201333 | SABER .035 PTA Dilatation Catheter | LIT | Substantially Equivalent | |
| K181592 | RAIN Sheath Transradial | DYB | Substantially Equivalent | |
| K180081 | RAILWAY Sheathless Access System | DYB | Substantially Equivalent | |
| K143412 | ADROIT Guiding Catheter | DQY | Substantially Equivalent | |
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | LIT | Substantially Equivalent | |
| K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM | FGE | Unknown | |
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | LIT | Substantially Equivalent | |
| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | LIT | Substantially Equivalent | |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | NTE | Substantially Equivalent | |
| K082143 | MICRO GUIDE CATHETER XP | PDU | Substantially Equivalent | |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | FGE | Unknown | |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | FGE | Unknown | |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | LIT | Substantially Equivalent | |
| K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE | DQX | Substantially Equivalent | |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K041796 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K034050 | CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F | DTK | Substantially Equivalent | |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | FGE | Unknown | |
| K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K032457 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K031197 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K030409 | SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM | FGE | Unknown | |
| K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | KNQ | Substantially Equivalent | |
| K023217 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K023116 | CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B | DTK | Unknown | |
| K021898 | SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K021345 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | Unknown | |
| K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP | DQY | Substantially Equivalent | |
| K020809 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | FGE | Unknown | |
| K020316 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU | DQO | Substantially Equivalent | |
| K020052 | SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K012993 | MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K012590 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | FGE | Unknown | |
| K010411 | PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM | FGE | Unknown | |
| K012087 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | FGE | Unknown | |
| K003920 | CORDIS M3 PTA DILATATION CATHETER | DQY | Substantially Equivalent | |
| K010083 | TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A | DTK | Substantially Equivalent | |
| K010445 | PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM | FGE | Unknown | |
| K003964 | TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B | DTK | Substantially Equivalent | |
| K003365 | S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) | FGE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1016427 | 1016427 | Cordis US Corp. | 14201 N.W. 60TH AVE., Miami Lakes, FL 33014 US | 2026 | and 12 more, listed in full below |
| 3004939290 | 3010142363 | Cordis US Corp. | 5452 Betsy Ross Dr, Santa Clara, CA 95054 US | 2026 | |
| 3025149222 | 3025149222 | Cordis US Corp. | 4080 Executive Drive, Southaven, MS 38672 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- FIWAlarm, Pillow Pressure
- DRQAmplifier And Signal Conditioner, Transducer Signal
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- DTCAnalyzer, Pacemaker Generator Function
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GOLAntigen, Ha (Including Ha Control), Rubella
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- GQIAntiserum, Cf, Cytomegalovirus
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- GDJClamp, Surgical, General & Plastic Surgery
- FIGClamp, Tubing, Blood, Automatic
- DXCClamp, Vascular
- DAKComplement C1q, Antigen, Antiserum, Control
- FMHContainer, Specimen, Sterile
- DWZDevice, Biopsy, Endomyocardial
- GWMDevice, Monitoring, Intracranial Pressure
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- KNQDilator, Esophageal
- DREDilator, Vessel, For Percutaneous Catheterization
- DTKFilter, Intravascular, Cardiovascular
- DTXGas Control Unit, Cardiopulmonary Bypass
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- DXYImplantable Pacemaker Pulse-Generator
- DXTInjector And Syringe, Angiographic
- GZXInstrument, Microsurgical
- GYKInstrument, Shunt System Implantation
- DYBIntroducer, Catheter
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- FIENeedle, Fistula
- DTZOxygenator, Cardiopulmonary Bypass
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
- FIBProtector, Transducer, Dialysis
- DTEPulse-Generator, Pacemaker, External
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- JXGShunt, Central Nervous System And Components
- KPMShunt, Peritoneal
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- FGEStents, Drains And Dilators For The Biliary Ducts
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FKPSystem, Dialysate Delivery, Single Patient
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
- JPHTest, Erythrocyte Sedimentation Rate
- DJCThin Layer Chromatography, Methamphetamine
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 170| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1511-2025 | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Open, Classified | |
| Z-1510-2025 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Open, Classified | |
| Z-1330-2025 | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. | Catheter manufactured at the incorrect length. | Class II | Open, Classified | |
| Z-0675-2024 | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct. | Class II | Open, Classified | |
| Z-0674-2024 | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct. | Class II | Open, Classified | |
| Z-0286-2024 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter | Non-sterile product labeled as sterile was distributed. | Class I | Open, Classified | |
| Z-1496-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1495-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1494-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1493-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1492-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1491-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1490-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1489-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1488-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1487-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1486-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1485-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1484-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-1483-2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | Class I | Open, Classified | |
| Z-0720-2023 | Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient. | There is a potential for separation at the male connector. | Class II | Open, Classified | |
| Z-1363-2022 | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. | Potential for stent dislodgement and associated failures related to two specific sizes of the device. | Class II | Open, Classified | |
| Z-0221-2022 | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. | There is a potential for distal tip dislodgement or separation. | Class II | Open, Classified | |
| Z-0220-2022 | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. | There is a potential for distal tip dislodgement or separation. | Class II | Open, Classified | |
| Z-0219-2022 | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. | There is a potential for distal tip dislodgement or separation. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain