Device Recall Pentax

  • Modelo / Serial
    EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Pentax Video Bronchoscope || Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

10 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031, A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051, A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065, A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078, A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091, A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121, A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136, A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159, A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173, A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193, A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214, A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235, A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252, A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277, A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290, A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317, A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328, A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385, A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405, A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419, A110421, A110422, A110424, A110438, A110439, A110440, A110454, A110462, A110464, A110466, A110468, A110470, A110473, A110474, A110476, A110480, A110483, A110491, A110492, A110495, A110496, A110497, A110498, A110499, A110501, A110502, A110518, A110520, A110521, A110524, A110525, A110527, A110534, A110535, A110538, A110547, A110549, A110550, A110553, A110554, A110555, A110574, A110581, A110582, A110587, A110588, A110589, A110590, A110591, A110593, A110594, A110595, A110596, A110598, A110599, A110600, A110601, A110602, A110607, A110610, A110612, A110614, A110615, A110616, A110617, A110619, A110620, A110621, A110623, A110625, A110626, A110633, A110649, A110651, A110652, A110654, A110665, A110666, A110667, A110668, A110669, A110670, A110671, A110672, A110674, A110675, A110676, A110677, A110678, A110680, A110682, A110683, A110684, A110686, A110692, A110694, A110695, H110699, H110700, H110701, H110703, H110704, H110705, H110706, H110707, H110708, H110709, H110710, H110711, H110712, H110714, H110715, H110716, H110717, H110718, H110719, H110721, H110723, H110729, H110733, H110736, H110737, H110738, H110740, H110749, H110754, H110767, H110773, H110774, H110775, H110779, H110780, H110781, H110782, H110783, H110784, H110786, H110788, H110789, H110790, H110791, H110792, H110793, H110794, H110795, H110796, H110797, H110799, H110800, H110802, H110803, H110805, H110807, H110819, H110822, H110823, H110825, H110826, H110827, H110828, H110830, H110831, H110832, H110834, H110835, H110837, H110838, H110840, H110842, H110844, H110845, H110846, H110849, H110850, H110851, H110852, H110853, H110858, H110859, H110860, H110861, H110862, H110863, H110865, H110866, H110867, H110868, H110869, H110870, H110871, H110872, H110873, H110876, H110877, H110880, H110881, H110882, H110883, H110890, H110891, H110892, H110893, H110894
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Video Duodenoscope
  • Manufacturer
  • Modelo / Serial
    EB-1970UK
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model #'s 9106 and 9108
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
  • Modelo / Serial
    Model Numbers: Ed-3490TK and ED-3270K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
  • Descripción del producto
    Video Duodenoscope || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
  • Manufacturer
  • Modelo / Serial
    Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Video Bronchoscope
  • Manufacturer
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