25 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
SE-300 VACUUM THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOKNOTLESS ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
9/10ULTAMET36MMHEADS+6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code KWA·April 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 7, 2011
CIDEX OPA SOLUTION
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code LRJ·May 23, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·April 24, 2019
IMPL TAPERED SP 3.7MM 10M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 27, 2023
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 3, 2023
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012