13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
FDA 510(k)
FDA Class 2
·Orthopedic
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304674509·
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 6, 2014
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
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
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