ela Medical Llc

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 8 건

  • 모델명 / 제조번호(시리얼번호)
    Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
  • 제품 설명
    ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
  • 모델명 / 제조번호(시리얼번호)
    Symphony DR 2250 serial numbers: 238WG020, 243WG055, 246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074, 303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and 320WG220.   Rhapsody DR 2510 Serial numbers: 318WJ010, 318WJ060 and 318WJ061
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
  • 제품 설명
    Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers DR model 614, VR model 615
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
  • 제품 설명
    Alto implantable cardioverter defibrillator
  • 모델명 / 제조번호(시리얼번호)
    devices manufactured between April 2003 and August 2004. Model 617 serial numbers: 241XH059, 305XH005 and 305XH014.   Model 627 serial numbers: 330YA541, 348YA563, 348YA571,  348YA573, 348YA576, 350YA594, 407YA604, 407YA630,  407YA635, 407YA644, 411YA001, 411YA002, 411YA011,  411YA014, 411YA015, 411YA016 and 418YA029.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
  • 제품 설명
    Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
  • 모델명 / 제조번호(시리얼번호)
    devices manufactured between April 2003 and August 2004. Model 615 serial number: 237XG065.   Model 625 serial numbers: 243XI009, 243XI060, 243XI075, 243XI089, 246XI019, 246XI031, 246XI076, 249XI044, 249XI045,  249XI093, 249XI106, 249XI123, 249XI134, 304XI069,  304XI070, 304XI087, 304XI095, 304XI117, 307XI016,  307XI040, 307XI041, 307XI050, 307XI053, 307XI093, 307XJ016, 312XI007, 312XI009, 312XI016, 312XI033, 312XI033, 312XI041, 312XI095, 312XI097, 312XI124, 402XI027, 402XI070, 404XI007, 404XI010, 404XI028, 404XI029, 404XI031, 404XI044, 409XI001, 409XI007,  409XI013, 409XI015, 409XI018, 413XI004, 414XI017 and 415XI025.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
  • 제품 설명
    Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
하나 더 3 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    ela Medical Llc, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA
  • 제조사 주소
    ela Medical Llc, 2905 NW Blvd Suite 40, Plymouth MN 55442
  • Source
    USFDA