Tachos

  • 모델명 / 제조번호(시리얼번호)
    Model Number 335 572 Serial numbers: 78011709 - 78011712, 78011714 ¿ 78011719, 78011725 ¿ 78011729, 78011759 ¿ 78011763, 78011769 ¿ 78011778, 78011780 ¿ 78011791, 78011793 - 78011829, 78011831, 78011833 ¿ 78011864, 78011866 ¿ 78011928, 78011930 ¿ 78011937, 78011939 ¿ 78011949, 78011951 ¿ 78011981, 78011983 ¿ 78011985, 78011987 ¿ 78011988, 78019000 -78019014, 78019016 ¿ 78019025, 78019027, 78019029 ¿ 78019035, 78019037 ¿ 78019051, 78019053 ¿ 78019066, 78019068 ¿ 78019081, 78019083, 78019084, 78019086 ¿ 78019091, 78019096 ¿ 78019099, 78019101 ¿ 78019105, 78019107 ¿ 780190122, 78019126 ¿ 780190129, 78019131 ¿ 78019140
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • 제품 설명
    Tachos DR - Implantable Cardioverter Defibrillator
  • Manufacturer
  • 1 Event

제조사

  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 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.
  • Manufacturer
  • 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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Number 122 499 Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707, 78012709 ¿ 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771, 78012791, 78012792, 78012794, 78012804, 78012809, 78012815 ¿ 78012820, 78012968, 78012987 ¿ 78012989, 78013072 ¿ 78013076, 78013092 ¿ 78013094, 78013099, 78013100, 78013165 ¿ 78013185, 78013194, 78013198, 78013200 ¿ 78013204, 78013206, 78013207, 78013210, 78013217 ¿ 78013220, 78013222, 78013224 ¿ 78013227, 78013230 ¿ 78013256, 78013258 ¿ 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297, 78013299, 78013315, 78013317, 78013321
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • 제품 설명
    Tachos DR - Atrial Tx
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Number 334 342 Serial numbers: 78050083 ¿ 78050088, 78050091 ¿ 78050095, 78050097, 78050098, 78050100, 78050103 ¿ 78050105, 78050107, 78050109, 78050110, 78050113, 78050117 ¿ 78050122, 78050124 ¿ 78050128, 78050133 ¿ 78050139, 78050142 ¿ 78050144, 78050162 ¿ 78050169
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • 제품 설명
    Tachos ATx
  • Manufacturer
하나 더 4 건 더