14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
X-Fix Line Additions
FDA 510(k)
FDA Class 2
·Orthopedic
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896074484·CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK CURVED J...
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017658·CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK CURVED JAW
ProLift
FDA UDI
Life Spine, Inc.·00190837086343·
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DOMAIN SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 8, 2014
CAPSUREFIX
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·December 1, 2025
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
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023