13 results
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64ms
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Sources: EU EUDAMED, US FDA
BEND IT TECHNOLOGIES LTD.
FDA registration
BEND IT TECHNOLOGIES LTD.·2 products·🇮🇱 Israel
Bendit®21 Microcatheter
FDA UDI
BEND IT TECHNOLOGIES LTD·17290018072049·The Bendit®21 Microcatheter is intended for use...
Bendit2.7 Steerable Microcatheter
FDA UDI
BEND IT TECHNOLOGIES LTD·17290018072001·The Bendit2.7™ Steerable Microcatheter is inten...
BENDIT21 MICROCATHETER
FDA Adverse Event
Malfunction
·BEND IT TECHNOLOGIES LTD.·Product code QJP·November 21, 2023
BENDIT21 MICROCATHETER
FDA Adverse Event
Malfunction
·BEND IT TECHNOLOGIES LTD.·Product code QJP·November 20, 2023
PACKAGE,350P,PP03,IT,350-BAS-IT-10
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·October 29, 2018
HEARTSINE SAMARITAN 350P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·October 11, 2019
HEARTSINE SAMARITAN 350P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
PACKAGE,350P,PP03,USB,IS,350-BAS-IS-10
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 8, 2019
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
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
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices