Device Recall Pentax

Manufacturer

  • Manufacturer Address
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and Internationally
  • Product Description
    Video Bronchoscope
  • Manufacturer
  • Model / Serial
    Model #: VNL-1570STK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and Internationally
  • Product Description
    Video Naso pharyngo Laryngoscopes
  • Manufacturer
  • Model / 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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Video Duodenoscope
  • Manufacturer
  • Model / Serial
    EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    EB-1970UK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
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