11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108159·Avex CX .018 LR5 D/HK (-17°T 2°A)
NA
FDA UDI
Synthes GmbH·10886982153616·4.5MM CORTEX SCREW 58MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113980·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1201-1...
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
FDA 510(k)
FDA Class 2
·Radiology
CREO STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 4, 2020
VENTILATOR, CONTINUOUS MINIMAL VENTILATORY SUPPORT, FACILITY
FDA Adverse Event
Other
·RESPIRONICS, INC.·Product code MNT·July 19, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 24, 2014
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019