10,000 results
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87ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FNL-10P, FIBER NASOPARHYNGOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FIBER LARYNGOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333232772·FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
FIBER LARYNGOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333232758·FIBER NASO PHARYNGO LARYNGOSCOPE INTUB 3 (REFUR...
PENTAX
FDA UDI
HOYA CORPORATION·04961333224272·NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES
FIBER LARYNGOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333232796·FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
FIBER LARYNGOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333232765·NASO-PHARYNGO-LRNGO PORTABLE (REFURBISHED)
FIBER LARYNGOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333232789·FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
PENTAX
FDA UDI
HOYA CORPORATION·04961333224234·NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES
FIBER NASO PHARYNGO LARYNGOSTROBOSCOPE
FDA UDI
PENTAX OF AMERICA, INC.·04961333240333·FIBER NASO PHARYNGO LARYNGOSCOPE (USED)
PENTAX
FDA UDI
HOYA CORPORATION·04961333224036·Perform cleaning, high-level disinfection, and/...
PENTAX
FDA UDI
HOYA CORPORATION·04961333224258·NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Agiliti Health
FDA UDI
SIZEWISE RENTALS, L.L.C.·00845699046386·Essentia™ Model # 65-05-0010 / Essentia Standar...
ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL
FDA UDI
Cynosure, LLC·00841494107963·ASSY, FINAL LASER, SCULPSURE, SUB ONLY BRAZIL
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 6, 2016
CAIRE FNL H36T TF 10LPM
FDA Adverse Event
Injury
·CAIRE, INC.·Product code BYJ·February 8, 2011
FNL LIBERATOR 45 TF G3 SPAIN
FDA Adverse Event
Other
·CAIRE, INC.·Product code BYJ·April 23, 2009
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOB·February 18, 2022
FNL STROLLER T SF CA M 6LPM
FDA Adverse Event
Other
·CAIRE INC·Product code BYJ·June 12, 2008
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOB·February 12, 2022