12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPACT INTUITIV Multiple-Use Pack
FDA 510(k)
FDA Class 2
·Ophthalmic
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
BD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code JKA·June 4, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014