Pentax

  • Modelo / Serial
    Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Bronchoscope || Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. 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.
  • Manufacturer
  • 1 Event

Fabricante

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

143 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Marketing Status of Device a. Class : 2 b. PMN : K090197 c. LST : D076884   EG-3870UTK A110013  EG-3870UTK A110014  EG-3870UTK A110015  EG-3870UTK A110016  EG-3870UTK A110018  EG-3870UTK A110021  EG-3870UTK A110022  EG-3870UTK A110023  EG-3870UTK A110024  EG-3870UTK A110025  EG-3870UTK A110026  EG-3870UTK A110028  EG-3870UTK A110029  EG-3870UTK A110030 EG-3870UTK A110031  EG-3870UTK A110033  EG-3870UTK A110034  EG-3870UTK A110035  EG-3870UTK A110038  EG-3870UTK A110040  EG-3870UTK A110041  EG-3870UTK A110042  EG-3870UTK A110044  EG-3870UTK A110045  EG-3870UTK A110046  EG-3870UTK A110047  EG-3870UTK A110048  EG-3870UTK A110050  EG-3870UTK A110051  EG-3870UTK A110052  EG-3870UTK A110053  EG-3870UTK A110054  EG-3870UTK A110055  EG-3870UTK A110056  EG-3870UTK A110057  EG-3870UTK A110058  EG-3870UTK A110059  EG-3870UTK A110060  EG-3870UTK A110061  EG-3870UTK A110062  EG-3870UTK A110063  EG-3870UTK A110064  EG-3870UTK A110065  EG-3870UTK A110066  EG-3870UTK A110067  EG-3870UTK A110068  EG-3870UTK A110069  EG-3870UTK A110070  EG-3870UTK A110071  EG-3870UTK A110075 2008/2/22  EG-3870UTK A110076 2008/2/26  EG-3870UTK A110078 2008/2/28  EG-3870UTK A110080 2008/3/19  EG-3870UTK A110081 2008/3/28  EG-3870UTK A110082 2008/3/28  EG-3870UTK A110083 2008/4/17  EG-3870UTK A110084 2008/5/16  EG-3870UTK A110085 2008/5/16  EG-3870UTK A110086 2008/5/16  EG-3870UTK A110087 2008/5/16  EG-3870UTK A110088 2008/5/21  EG-3870UTK A110090 2008/6/16  EG-3870UTK A110093 2008/8/18  EG-3870UTK A110094 2008/8/18  EG-3870UTK A110095 2008/8/18  EG-3870UTK A110096 2008/8/27  EG-3870UTK A110098 2008/9/5  EG-3870UTK A110099 2008/9/18  EG-3870UTK A110100 2008/9/30  EG-3870UTK A110101 2008/9/29  EG-3870UTK A110104 2008/10/2  EG-3870UTK A110105 2008/10/7  EG-3870UTK A110106 2008/11/11  EG-3870UTK A110107 2008/11/10  EG-3870UTK A110108 2008/11/11  EG-3870UTK A110109 2009/1/13  EG-3870UTK A110110 2008/11/7  EG-3870UTK A110111 2008/11/25  EG-3870UTK A110112 2008/12/8  EG-3870UTK A110113 2008/12/8  EG-3870UTK A110114 2008/12/24  EG-3870UTK A110115 2009/1/30  EG-3870UTK A110116 2009/2/10  EG-3870UTK A110117 2009/2/24  EG-3870UTK A110118 2009/4/21  EG-3870UTK A110119 2009/5/7  EG-3870UTK A110120 2009/4/16  EG-3870UTK A110121 2009/4/28  EG-3870UTK A110122 2009/5/27  EG-3870UTK A110123 2009/6/18  EG-3870UTK A110124 2009/7/25  EG-3870UTK A110125 2009/8/10  EG-3870UTK A110126 2009/8/19  EG-3870UTK A110127 2009/8/5  EG-3870UTK A110128 2009/8/11 EG-3870UTK A110129 2009/9/10  EG-3870UTK A110130 2009/8/11  EG-3870UTK A110131 2009/10/8  EG-3870UTK A110133 2009/8/19 EG-3870UTK A110134 2009/8/25  EG-3870UTK A110135 2009/8/25  EG-3870UTK A110136 2009/8/27  EG-3870UTK A110137 2009/8/28  EG-3870UTK A110138 2009/9/3  EG-3870UTK A110139 2009/9/17  EG-3870UTK A110140 2009/9/17  EG-3870UTK A110141 2009/10/2  EG-3870UTK A110142 2009/10/6  EG-3870UTK A110143 2009/10/15  EG-3870UTK A110144 2009/10/23  EG-3870UTK A110145 2009/11/4  EG-3870UTK A110146 2009/11/10  EG-3870UTK A110147 2009/12/19  EG-3870UTK A110148 2009/12/26  EG-3870UTK A110149 2010/2/26  EG-3870UTK A110150 2010/1/25  EG-3870UTK A110151 2010/1/25  EG-3870UTK A110152 2010/2/2  EG-3870UTK A110153 2010/2/8  EG-3870UTK A110154 2010/2/12  EG-3870UTK A110155 2010/2/19  EG-3870UTK A110156 2010/2/19  EG-3870UTK A110161 2010/3/8  EG-3870UTK A110162 2010/3/8  EG-3870UTK A110163 2010/3/18  EG-3870UTK A110164 2010/4/14  EG-3870UTK A110165 2010/4/16  EG-3870UTK A110166 2010/4/20  EG-3870UTK A110167 2010/4/20  EG-3870UTK A110168 2010/4/21  EG-3870UTK A110169 2010/4/22  EG-3870UTK A110170 2010/4/23  EG-3870UTK A110172 2010/4/28  EG-3870UTK A110173 2010/5/8  EG-3870UTK A110174 2010/5/8  EG-3870UTK A110175 2010/5/10  EG-3870UTK A110177 2010/5/14  EG-3870UTK A110178 2010/5/21  EG-3870UTK A110179 2010/5/26  EG-3870UTK A110180 2010/6/1  EG-3870UTK A110181 2010/6/1  EG-3870UTK A110182 2010/6/8  EG-3870UTK A110183 2010/6/8  EG-3870UTK A110184 2010/6/15  EG-3870UTK A110186 2010/6/22  EG-3870UTK A110192 2010/7/8  EG-3870UTK A110193 2010/7/12  EG-3870UTK A110194 2010/7/13  EG-3870UTK A110195 2010/7/22  EG-3870UTK A110196 2010/7/26  EG-3870UTK A110199 2010/7/29  EG-3870UTK A110200 2010/7/27  EG-3870UTK A110203 2010/8/2  EG-3870UTK A110205 2010/8/6  EG-3870UTK A110206 2010/8/9  EG-3870UTK A110208 2010/9/28  EG-3870UTK A110210 2010/8/30 EG-3870UTK A110211 2010/8/31  EG-3870UTK A110213 2010/11/16  EG-3870UTK A110214 2010/10/12  EG-3870UTK A110215 2010/10/1  EG-3870UTK A110216 2010/10/1  EG-3870UTK A110217 2010/10/12  EG-3870UTK A110218 2010/10/13  EG-3870UTK A110219 2010/10/18  EG-3870UTK A110221 2010/10/22  EG-3870UTK A110222 2010/11/17  EG-3870UTK A110224 2010/11/22  EG-3870UTK A110225 2010/12/27  EG-3870UTK A110226 2010/11/29  EG-3870UTK A110227 2010/12/27  EG-3870UTK A110228 2010/12/15  EG-3870UTK A110229 2010/12/16  EG-3870UTK A110230 2011/1/21  EG-3870UTK A110231 2011/1/21  EG-3870UTK A110232 2011/1/28  EG-3870UTK A110233 2011/1/28  EG-3870UTK A110234 2011/2/4  EG-3870UTK A110235 2011/4/4  EG-3870UTK A110236 2011/2/16  EG-3870UTK A110237 2011/2/15  EG-3870UTK A110239 2011/4/4  EG-3870UTK A110240 2011/4/11  EG-3870UTK A110241 2011/5/12  EG-3870UTK A110242 2011/5/19  EG-3870UTK A110243 2011/5/19  EG-3870UTK A110244 2011/5/26  EG-3870UTK A110245 2011/5/24  EG-3870UTK A110249 2011/6/8  EG-3870UTK A110250 2011/6/8  EG-3870UTK A110253 2011/6/29  EG-3870UTK A110254 2011/6/14  EG-3870UTK A110255 2011/6/15  EG-3870UTK A110256 2011/6/29  EG-3870UTK A110257 2011/6/29  EG-3870UTK A110258 2011/6/29
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    EG-3870UTK, Pentax Ultrasound Video Gastroscope. || The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model: EG-3630U  A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140 E110188 E110285 E010064 E01039 E110141 E110193 E110287 E010066 E01042 E110144 E110195 E110289 E010069 E01043 E110145 E110202 E110290 E010070 E01046 E110146 E110205 E110306 E010075 E01054 E110147 E110208 E110307 E010077 E01061 E110156 E110210 E110308 E010078 E01062 E110157 E110219  Model: EG-3830UT  E110067 E110160 E110204 E110275 E110374 E110070 E110163 E110206 E110277 E110377 E110074 E110165 E110212 E110286 E110379 E110079 E110168 E110214 E110289 E110426 E110082 E110171 E110224 E110292 E110428 E110093 E110172 E110228 E110295 E110433 E110095 E110174 E110230 E110309 E110439 E110108 E110183 E110243 E110310 E110442 E110126 E110186 E110255 E110323 E110444 E110142 E110189 E110263 E110331 E110454 E110152 E110195 E110265 E110340 E110517 E110153 E110196 E110268 E110341  Model: FG-36UX  A01014 A01049 A01079 A01100 A01166 A01019 A01053 A01080 A01104 A01168 A01020 A01054 A01081 A01105 A01174 A01029 A01055 A01082 A01116 A01183 A01030 A01056 A01084 A01122 A01184 A01033 A01057 A01086 A01126 A01186 A01036 A01068 A01092 A01131 A110260 A01040 A01070 A01096 A01137 A110268 A01046 A01074 A01098 A01142  Model: EG-3870UTK  A110013 A110060 A110095 A110125 A110154 A110021 A110061 A110096 A110126 A110155 A110022 A110062 A110098 A110127 A110156 A110024 A110063 A110099 A110128 A110161 A110025 A110065 A110100 A110129 A110162 A110026 A110067 A110101 A110130 A110163 A110028 A110068 A110104 A110133 A110164 A110029 A110069 A110105 A110134 A110165 A110031 A110070 A110106 A110135 A110166 A110033 A110071 A110107 A110138 A110167 A110038 A110073 A110108 A110139 A110168 A110040 A110076 A110110 A110140 A110169 A110041 A110077 A110111 A110141 A110172 A110042 A110078 A110112 A110142 A110174 A110043 A110080 A110113 A110143 A110175 A110044 A110081 A110114 A110144 A110177 A110045 A110082 A110115 A110145 A110179 A110046 A110084 A110116 A110146 A110180 A110050 A110085 A110117 A110147 A110181 A110051 A110086 A110118 A110148 A110182 A110052 A110087 A110119 A110149 A110183 A110053 A110089 A110121 A110150 A110192 A110054 A110090 A110122 A110151 A110195 A110056 A110092 A110123 A110152 A110196 A110059 A110093 A110124 A110153 A110199 A110203 A110256 A110315 A110379 A110447 A110205 A110257 A110318 A110380 A110448 A110208 A110258 A110320 A110381 A110449 A110210 A110259 A110321 A110383 A110450 A110211 A110261 A110322 A110384 A110451 A110213 A110264 A110323 A110385 A110452 A110214 A110265 A110324 A110387 A110453 A110215 A110266 A110325 A110388 A110454 A110216 A110267 A110326 A110391 A110457 A110217 A110270 A110334 A110393 A110458 A110218 A110271 A110335 A110394 A110459 A110221 A110272 A110336 A110398 A110460 A110222 A110273 A110337 A110401 A110461 A110224 A110276 A110338 A110406 A110462 A110226 A110277 A110339 A110407 A110463 A110227 A110279 A110340 A110410 A110464 A110228 A110280 A110341 A110411 A110465 A110229 A110282 A110342 A110414 A110466 A110230 A110284 A110343 A110416 A110467 A110231 A110285 A110344 A110417 A110470 A110232 A110286 A110345 A110419 A110472 A110233 A110287 A110346 A110420 A110473 A110234 A110288 A110348 A110425 A110475 A110235 A110289 A110350 A110426 A110476 A110236 A110290 A110351 A110427 A110477 A110237 A110291 A110352 A110429 A110479 A110239 A110292 A110353 A110431 A110480 A110240 A110293 A110355 A110433 A110481 A110241 A110294 A110356 A110434 A110482 A110242 A110295 A110357 A110435 A110483 A110243 A110299 A110359 A110438 A110484 A110244 A110300 A110360 A110439 A110485 A110245 A110307 A110361 A110440 A110486 A110248 A110309 A110363 A110441 A110488 A110249 A110310 A110368 A110442 A110492 A110250 A110311 A110372 A110443 A110253 A110313 A110375 A110444 A110255 A110314 A110376 A110445
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    EG-3630U Ultrasound Video Gastroscope || EG-3830UT Ultrasound Video Gastroscope || EG-3870UTK Ultrasound Video Gastroscope || FG-36UX Ultrasound Fiber Gastroscope || Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
  • Manufacturer
  • Modelo / Serial
    Model No. OF-B130 OF-B194, all units.
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
  • Descripción del producto
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    HOYA: PENTAX Flexible video duodenoscope, PENTAX Flexible fiber duodenoscope
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    HOYA: PENTAX Endscopes (multiple types)
  • Manufacturer
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