13 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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Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
FDA 510(k)
FDA Class 2
·Anesthesiology
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087630·
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
FDA 510(k)
FDA Class 2
·Orthopedic
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 6, 2011
9615050-2013-01447
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·May 30, 2013
SUTURE
FDA Adverse Event
Injury
·ALCON PRECISION DEVICE·Product code GAR·September 4, 2008
BD PRECISIONGLIDE® SYRINGE NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·September 19, 2018
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 20, 2019
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
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016