10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TSX Implants
FDA 510(k)
FDA Class 2
·Dental
Electric Wheelchair (Model: S7110)
FDA 510(k)
FDA Class 2
·Physical Medicine
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
FDA 510(k)
FDA Class 2
·Orthopedic
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 3, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·August 23, 2011
*
FDA Adverse Event
Malfunction
·SMITH MEDICAL ASD, INC.·Product code FMF·July 3, 2013
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
FDA Enforcement
Class II
·Terminated·Acumed LLC·May 7, 2014