13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA LITE SP100 ELISA
FDA 510(k)
FDA Class 2
·Immunology
CT LUCIA
FDA UDI
CARL ZEISS MEDITEC PRODUCTION, LLC·00843045100836·3-piece, monofocal, hydrophobic, acrylic, intra...
RANDOX FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOBLAST
FDA Adverse Event
Injury
·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2013
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
BD PRN ADAPTER
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FPA·June 5, 2025
BD PRN ADAPTER
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·May 30, 2025
ACT ARTIC E1 HIP BRG 28X46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 15, 2021
BD PRN ADAPTER
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FPA·April 28, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012