139 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
FDA 510(k)
FDA Class 2
·Cardiovascular
THREADED ROD
FDA UDI
Biomet Orthopedics, LLC·00887868005862·
Valkyrie Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391422·Plate Holder
CLARREN HELMET
FDA 510(k)
FDA Class 2
·Neurology
GUARDIAN LIMB SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SSW CARBIDE CAD CAM
FDA UDI
Ss White Burs, Inc.·D690SSWWIE07303520012·CAD/CAM CARBIDE LAZER SHARP SSWWIE-073035-20-01...
TRANSTART STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·April 6, 2013
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 21, 2011
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·March 6, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code FGE·December 13, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 24, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 17, 2023
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code GBO·October 11, 2021
ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 1, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 5, 2024
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·August 6, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 11, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 11, 2020
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·November 30, 2020