12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CMI E-Z FLO BULB P.N. 701
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202507·Interbody, 9mm x 32mm x 12mm, 8 deg
WaveForm TA
FDA UDI
Seaspine Orthopedics Corporation·10889981243678·Interbody, 9mm x 32mm x 12mm, 8 Deg, 3D
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981209629·Trial, 9mm x 32mm x 12mm, 8 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194512·Interbody, 9mm x 32mm x 12mm, 8 deg
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
FDA 510(k)
FDA Class 2
·General Hospital
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
AUTOCLAVABLE HANDLES, OVERMOLDED
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·April 3, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTINS INC.·Product code LZG·January 18, 2013
GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM
FDA Adverse Event
Malfunction
·GENDEX DENTAL SYSTEMS·Product code EHD·December 17, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020