11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STOMAHESIVE SKIN BARRIER STERILE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106325·KIT, INDIVIDUAL
ENSITE VERISMO SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO·Product code GJS·April 11, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 29, 2012
R/B RLOC LHOLE SHL 58MM SZ 25
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·October 28, 2020
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
ARCOMXL RLC 10DEG 36MM SZ25
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·October 28, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020