14 results
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19ms
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Sources: EU EUDAMED, US FDA
OXYGEN MASKS 82400 & 82405
FDA 510(k)
FDA Class 1
·Anesthesiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909134552·REVELATION DIAMOND 863-012M - 5 PACK
ORBITAL FLOOR PLATE
FDA Adverse Event
Injury
·SYNTHES·Product code JEY·March 28, 2016
SOLITAIRE FR REVASCULARIZATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ControlRad Select Model Z
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD 5
FDA Adverse Event
Other
·INSULET CORPORATION·Product code QFG·September 25, 2024
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 14, 2013
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LOX·November 12, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016
1.5MM RAPID RESORB ORBTL FL PLW/BENDING TEMPLATE/35MM-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JEY·March 29, 2016
1.5MM RAPID RESORB ORBTL FL PLW/BENDING TEMPLATE/35MM-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JEY·March 29, 2016
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·November 2, 2011
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
FDA Recall
Open, Classified
·Product code QFG·November 30, 2023