11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
FDA 510(k)
FDA Class 2
·Orthopedic
GC Initial™
FDA UDI
Gc America Inc.·J0228745471·GC Initial™ Ti Opaqus Dentin Mod. ODM-1, 50g
Legacy™ Plastic Engaging Temporary Abutment-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307134091·
Legacy™ Plastic Engaging Temporary Abutment-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111672·
ANGIOSCOPY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
FDA 510(k)
FDA Class 1
·Microbiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 22, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·December 15, 2012
CritiCool, thermoregulation device
FDA Recall
Open, Classified
·Belmont Instrument Corporation·Product code DWJ·July 20, 2021
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
FDA Recall
Open, Classified
·Belmont Instrument LLC·Product code FRN·January 2, 2025