29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVA (Augmented Vascular Analysis)
FDA 510(k)
FDA Class 2
·Radiology
Dornier Thulio Performance Fiber
FDA UDI
INNOVAQUARTZ LLC·00816959021887·
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023448·THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
Puget Sound Energy - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal
OES Elite Ureteroscopes and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESPIEVENTS, VERSION 4.2
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 27, 2014
N/A
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLQ·August 11, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·March 5, 2014
COBAS® MPX - 96T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2013
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·November 6, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MGB·March 25, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MGB·March 25, 2014
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 25, 2014
THERASPHERE
FDA Adverse Event
Death
·BIOCOMPATIBLES UK LTD·Product code NAW·June 17, 2016