46 results
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19ms
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Sources: EU EUDAMED, US FDA
HEMOSAFE
FDA 510(k)
FDA Class 2
·Hematology
MRSA/SA ELITe MGB
FDA UDI
Elitechgroup Mdx LLC·03661540950001·MRSA/SA ELITe MGB™ is a qualitative in vitro di...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left
NA
FDA UDI
STRYKER CORPORATION·07613327169195·
INTRA-AORTIC BALLOON CATHETER
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 30, 1998
EZ CONNECT
FDA 510(k)
FDA Class 2
·Dental
ENDOCLEAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIODESIGN 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTM·April 3, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2007
Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
FDA Recall
Terminated
·Cook, Inc.·Product code HCG·May 8, 2008
Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
FDA Recall
Terminated
·Cook, Inc.·Product code HCG·May 8, 2008
Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404.
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-38. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-38. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 FRENCH, 65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 19UT Gage., 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-65. Cook Inc., Bloomington, IN 47404.
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007