11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
FDA 510(k)
FDA Class 2
·Microbiology
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123347·MORELAND REV INST TREPHINE REAMER 18.5mm 5.5 IN
Portex
FDA UDI
ICU MEDICAL, INC.·15019517110852·
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE
FDA 510(k)
FDA Class 2
·Physical Medicine
Applied BioPhotonics Phototherapy System ABPT1003
FDA 510(k)
FDA Class 2
·Physical Medicine
VERSATAP SUTURE ANCHOR
FDA Adverse Event
Malfunction
·ORTHO-DESIGN·Product code MBI·September 15, 2025
BD NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 9, 2025
MATRIX2 STADNARD 360 SR COIL
FDA Adverse Event
Injury
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 19, 2008
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013