15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803505·Tilt Ratchet
NEOWIRE PTA/PTCA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
FDA 510(k)
FDA Class 2
·Cardiovascular
VENTED AUTOFEED HUMIDIFICATION CHAMBERS
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 12, 2011
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 3, 2012
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 9, 2013
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 1, 2011
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·February 8, 2012
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 1, 2012
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025