17 results
·
58ms
·
Sources: EU EUDAMED, US FDA
TUPER MEDICAL CO., LTD.
FDA registration
TUPER MEDICAL CO., LTD.·28 products·🇨🇳 China
ChangShu Super Medical Equipment Co.,Ltd.
Manufacturer
🇨🇳 China
Super Health Medical (Qingdao) Co.,Ltd.
Manufacturer
🇨🇳 China
Yangzhou Super Union Medical Material Co., Ltd
Manufacturer
🇨🇳 China
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DRE·November 3, 2011
KROGER STERILE PADS 3 X 3 12-PLY 10CT
FDA Adverse Event
Malfunction
·YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD.·Product code FRL·September 28, 2015
CVS HEALTH
FDA Adverse Event
Injury
·YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD.·Product code NAB·October 4, 2017
CVS
FDA Adverse Event
Injury
·YANGZHOU SUPER-UNION MEDICAL MATERIAL CO., LTD.·Product code NAB·May 11, 2022
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 Recall
Terminated
·Cordis Corporation·Product code LOX·January 31, 2011
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 Recall
Terminated
·Cordis Corporation·Product code LOX·January 31, 2011
BioDomi GmbH
Authorized representative
🇩🇪 Germany·28 Manufacturers·86 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
Wellkang Ltd
Authorized representative
259 Manufacturers·3500 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Med Consulting Srl
Importer
🇮🇹 Italy·12 Manufacturers
Cleverstore.ro Srl
Importer
🇷🇴 Romania·49 Manufacturers