15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ET III Bio-SA Fixture System
FDA 510(k)
FDA Class 2
·Dental
Masel
FDA UDI
Ortho Organizers, Inc.·00190707040956·Choice™ Jaraback w/ Cutter
ProLift
FDA UDI
Life Spine, Inc.·00190837105914·Static Expandable Cage Trial, 12mm x 28mm x 10m...
LENSX LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 11, 2018
PENUMBRA SYSTEM MAX ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013
COMPOSIX MESH E/X
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·June 29, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
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