80 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOMTEC-ARENA
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023288·270 Micron SU Thulio Performance 3m Fiber
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023486·THULIO LL-R TM 600µM 3M PERF. FIBER 3ST 10X USE
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512664·"An absorbent paper points is an endodontic pap...
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EVIS EXERA III COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·October 1, 2025
EVIS EXERA III COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·December 21, 2025
EVIS EXERA III COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·June 12, 2025
EVIS EXERA II DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDT·July 11, 2024
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 12, 2018
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·January 29, 2026
GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·June 5, 2025
GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·February 21, 2025
MITEK OMNISPAN MENISCAL REPAIR SYSTEM, 12 DEGREE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·October 27, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·July 21, 2025
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDT·April 29, 2025