13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABC D-FLEX PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 8, 2014
ECHELON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 29, 2024
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·September 29, 2024
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·April 26, 2017
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
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016