178 results
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Sources: EU EUDAMED, US FDA
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Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·July 3, 2013
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
FDA Enforcement
Class II
·Terminated·Cordis Corporation·October 3, 2012
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
FDA Enforcement
Class II
·Terminated·Cordis Corporation·October 3, 2012
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
FDA Recall
Terminated
·Cordis Corporation·Product code DYB·October 15, 2009
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
FDA Recall
Terminated
·Cordis Corporation·Product code DQO·November 21, 2011
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
FDA Recall
Terminated
·Cordis Corporation·Product code DQO·November 21, 2011
CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503558X
FDA Recall
Terminated
·Cordis Corporation·Product code DXQ·July 21, 2006
CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503658
FDA Recall
Terminated
·Cordis Corporation·Product code DXQ·July 21, 2006
CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503658X
FDA Recall
Terminated
·Cordis Corporation·Product code DXQ·July 21, 2006
CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503558.
FDA Recall
Terminated
·Cordis Corporation·Product code DXQ·July 21, 2006
CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008
CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250, Distributed by Cordis Corporation, Miami Lakes, FL 33014
FDA Recall
Terminated
·Cordis Corporation·Product code LOX·January 14, 2008