Biotronik Inc

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 11 건

  • 모델명 / 제조번호(시리얼번호)
    Model No. 355 572 Serial Nos. 78011361, 78011362, 78011364, 78011365, 78011376, 78011378-78011385, 78011389-78011414, 78011416-78011424, 78011426-78011430, 78011432-78011464, 78011466-78011491, 78011493-78011499, 78011600-78011617, 78011619, 78011621-78011639, 78011641, 78011643, 78011647-78011654, 78011656-78011660, 78011684-78011686, 78011689, 78011691, 78011692, 78011699-78011701, 78011704-78011708, 78011713, 78011720-78011723, 78011730-78011743, 78011745-78011758, 78011764-78011768, 78011779
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
  • 제품 설명
    Tachos DR - Implantable Cardioverter Defibrillator.
  • 모델명 / 제조번호(시리얼번호)
    Model No. 334 341 Serial Nos. 78062821, 78062822, 78062831, 78062838, 78062839, 78062901, 78062957
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
  • 제품 설명
    Deikos A+ Implantable Cardioverter Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077, 78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125,78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
  • 제품 설명
    Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
  • 모델명 / 제조번호(시리얼번호)
    Part number 330444. Serial numbers 78110211, 78110212, 78110215, 78110226, 78110227, 78110229, 78110231, 78110233, 78110234, 78110235, 78110270, 78110287, 78110288, 78110290, 78110292, 78110294, 78110295, 78110296, 78110297, 78110298, 78110299, 78110300, 78110302, 78110303, 78110305, 78110306, 78110307, 78110308, 78110309, 78110310, 78110315, 78110316, 78110318, 78110325, 78110331, 78110335, 78110336, 78110337, 78110339, 78110340, 78110341, 78110342, 78110344, 78110345, 78110347, 78110348, 78110349, 78110351, 78110352, 78110361, 78110362, 78110363, 78110364, 78110365, 78110376, 78110378, 78110380, 78110387, 78110388, 78110390, 78110401, 78110402, 78110403, 78110404, 78110405, 78110406, 78110407, 78110408, 78110411, 78110412, 78110413, 78110414, 78110416, 78110417, 78110418, 78110420, 78110421, 78110454, 78110455, 78110457, 78110459, 78110461, 78110462, 78110463, 78110464, 78110465, 78110466, 78110467, 78110468, 78110469, 78110470, 78110471, 78110472, 78110477, 78110479, 78110483, 78110484, 78110485, 78110486, 78110487, 78110488, 78110494, 78110496, 78110497, 78110501, 78110504, 78110505, 78110507, 78110510, 78110511, 78110512, 78110513, 78110520, 78110525, 78110526, 78110530, 78110535, 78110536, 78110537, 78110538, 78110539, 78110540, 78110541, 78110542, 78110544, 78110545, 78110546, 78110547, 78110550, 78110551, 78110559, 78110561, 78110565, 78110566, 78110568, 78110569, 78110571, 78110572, 78110574, 78110575, 78110576, 78110577, 78110579, 78110585, 78110587, 78110588, 78110589, 78110592, 78110595, 78110596, 78110597, 78110598, 78110599, 78110600, 78110601, 78110602, 78110603, 78110604, 78110605, 78110606, 78110608, 78110609, 78110611, 78110612, 78110614, 78110621, 78110627, 78110628, 78110629, 78110632, 78110633, 78110634, 78110636, 78110639, 78110641, 78110642, 78110643, 78110650, 78110651, 78110658, 78110690, 78110691, 78110692, 78110694, 78110704, 78110705, 78110706, 78110766, 78110773, 78110786, 78110789, 78110791, 78110793, 78110795, 78110799, 78110800, 78110811, 78110814, 78110815, 78110823, 78110824, 78110827, 78110828, 78110833, 78110835, 78110838, 78110843, 78110844, 78110845, 78110856, 78110857, 78110865, 78110866, 78110867, 78110870, 78110872, 78110875, 78110876, 78110877, 78110878, 78110879, 78110880, 78110881, 78110882, 78110883, 78110884, 78110885, 78110897, 78110905, 78110906, 78110907, 78111001, 78111002, 78111003, 78111005, 78111006, 78111021, 78111022, 78111023, 78111024, 78111025, 78111071, 78111076, 78111079, 78111080, 78111091, 78111092, 78111096, 78111097, 78111142, 78111148, 78111150, 78111155, 78111162, 78111171, 78111181, 78111201, 78111203, 78111206, 78111207, 78111208, 78111210, 78111220, 78111231, 78111239, 78111257, 78111259, 78111260, 78111261, 78111270, 78111276, 78111277, 78111278, 78111279, 78111280, 78111281, 78111282, 78111283, 78111290, 78111294, 78111296, 78111297, 78111313, 78111316, 78111327, 78111328, 78111330, 78111331, 78111333, 78111334, 78111335, 78111336, 78111337, 78111339, 78111340, 78111341, 78111343, 78111345, 78111351, 78111353, 78111361, 78111362, 78111406, 78111409, 78111430, 78111439, 78111440, 78111444, 78111447, 78111448, 78111449, 78111496, 78111498, 78111502, 78111517, 78111519, 78111520, 78111522, 78111594, 78111655, 78111666, 78111667, 78111668, 78111669, 78111802, 78111828, 78111832, 78111839, 78111840, 78111841, 78111843, 78111844, 78111845, 78111846, 78111888, 78111900, 78111901, 78111902, 78111909, 78111911, 78111912, 78111913, 78111914, 78111915, 78111917, 78111918, 78111924, 78111961, 78111979, 78111980, 78111982, 78111985, 78111993, 78111994, 78111995, 78111996, 78111997, 78111998, 78112018, 78112029, 78112045, 78112046, 78112100, 78112105, 78112111, 78112112, 78112113, 78112114, 78112116, 78112117, 78112120, 78112149, 78112150, 78112151, 78112158, 78112162, 78112163, 78112178, 78112180, 78112182, 78112201, 78112211, 78112225, 78112226, 78112235, 78112244, 78112258, 78112259, 78112260, 78112261, 78112267, 78112285, 78112294, 78112295, 78112296, 78112297, 78112300, 78112302, 78112303, 78112310, 78112312, 78112314, 78112315, 78112316, 78112317, 78112318, 78112319, 78112321, 78112322, 78112323, 78112324, 78112325, 78112327, 78112338, 78112339, 78112345, 78112346, 78112349, 78112350, 78112360, 78112361, 78112362, 78112377, 78112381, 78112384, 78112387, 78112388, 78112389, 78112392, 78112446, 78112477, 78112478, 78112493, 78112494, 78112495, 78112496, 78112497, 78112500, 78112503, 78112504, 78112506, 78112507, 78112508, 78112509, 78112549, 78112550, 78112552, 78112554, 78112555, 78112556, 78112557, 78112613, 78112614, 78112615, 78112617, 78112618, 78112619, 78112620, 78112621, 78112622, 78112623, 78112624, 78112644, 78112645, 78112647, 78112648, 78112676, 78112831, 78112835
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
  • 제품 설명
    Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.
  • 모델명 / 제조번호(시리얼번호)
    Part number 331135. Serial numbers 78140020, 78140021, 78140026, 78140027, 78140029, 78140035, 78140037, 78140038, 78140039, 78140045, 78140046, 78140048, 78140049, 78140051, 78140052, 78140053, 78140054, 78140055, 78140056, 78140057, 78140058, 78140059, 78140060, 78140061, 78140062, 78140063, 78140064, 78140065, 78140066, 78140067, 78140070, 78140071, 78140072, 78140073, 78140102, 78140103, 78140104, 78140105, 78140109, 78140111, 78140112, 78140113, 78140114, 78140124, 78140132, 78140134, 78140135, 78140136, 78140139
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
  • 제품 설명
    Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. || The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid || the physician''s assessment of a patient''s condition and the performance of the implanted device.
하나 더 6 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Biotronik Inc, 6024 Jean Rd, Lake Oswego OR 97035-5308
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA