57 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ECAT LSO PET/CT 16
FDA 510(k)
FDA Class 2
·Radiology
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184553·Locking Screws, Cross-Pin
RAPIDD HIGHSPEED DENTAL HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AIMING ARM/ RADIOLUCENT
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·June 15, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·MERZ AESTHETICS, INC.·Product code LMH·May 6, 2011
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
FREEDOM CONSTRAINED HEAD +6MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWZ·March 27, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 1, 2011
PROTIME MICROCOAGULATION INSTRUMENT
FDA Adverse Event
Other
·INTERNATIONAL TECHNIDYNE CORP.·Product code GJS·March 27, 2008
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·August 12, 2015
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 7, 2025