14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIGR SURGICAL MESH , MODEL WK-6
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ConMed/Linvatec
FDA UDI
Provision·B504OM50922240·
CONMED
FDA UDI
Conmed Corporation·10845854004517·ROUND BUR, LONG, CARBIDE, 2 MM
NA
FDA UDI
STERILMED, INC.·10888551018272·BUR CARBIDE MICRO ROUND 6 FLUTES LONG
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 3, 2013
DUROM ACETABULAR COMPONENT 50/44 CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 20, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·November 20, 2013
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013