The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
관련기사 - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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모델명 / 제조번호(시리얼번호)
159, 183
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
US: WA OUS: China, Spain, Korea, Republic of, Germany
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제품 설명
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
- Manufacturer
- 1 Event
제조사
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제조사 주소
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
- 제조사 모회사 (2017)
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Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 229 건
데이터에 대해 더 자세히 알아보기 여기
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모델명 / 제조번호(시리얼번호)
Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
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제품 설명
Allura XPER FD 20 and and Allura CV20; || Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
versions D.03, E.0, or E.01 of the software
- 의료기기 분류등급
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의료기기 등급
Unclassified
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이식된 장치?
No
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유통
Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
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제품 설명
Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Serial numbers are: P16C080002, P16E080005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E090006, P16E090007, P16E090009, P16E090012, P16E090003, P16E090010, P16E090011, P16E090013, P16EM09003, P16EM09004, P16E090002, P16E090014, P16E090015, P16EM08003, P16E090016, P16E090018, P16E090019, P16E090020, P16E090021, P16E090026, EP16E090001, P16E090028, P16E090027, P16E090017, P16EM09002, P16E090024, P16E090025, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, P16C090001, EP16E090010, EP16E090011, EP16E090012, EP16E090014, EP16E090015, EP16E100001, EP16E100002, EP16E100004, EP16E100003, EP16E100005, EP16E100006, EP16E100007, EP16E090013, EP16E100008, EP16E100009, EP16E100010, P16C100001, EP16E100011, EP16E100012, EP16E100013, EP16E100014, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, P16C080001, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100027, EP16E100026, EP16E100030, EP16E100031, EP16E100029, P16C100003, EP16E100025, EP16E100028, P16C100002, EP16E100034, EP16E100033, EP16E100032, EP16E100035, EP16E100036, EP16E100037, P16E100002, P16C100004, EP16E100039, EP16E100038, EP16E100042, EP16E100043, EP16E100041, EP16E100044, EP16E100046, EP16E100045, EP16E100048, EP16E100047, EP16E100051, EP16E100049, EP16E100050, EP16E100053, EP16E100052, EP16E100054, EP16E100056, EP16E100055, P16C100005, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, P16C100007, EP16E100067, EP16ER100003, EP16ER100004, EP16ER100005, EP16E100070, EP16E100069, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100078, EP16E100075, EP16E100076, EP16E100077, EP16E100079, EP16E100080, EP16E100082, EP16E100081, EP16E100083, EP16E100084, P16C100008, P16C100009, EP16E100085, EP16E100086, EP16E100087, P16C100010, EP16E100088, EP16E100089, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100092, P16C100014, P16C100015, EP16E100095, P16C100011, EP16E100096, EP16E100097, EP16E100098, P16C100017, EP16E100099, EP16E100100, EP16E100101, EP16E100102, P16C100013, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100109, EP16E100107, P16C100012, EP16E100108, EP16E100111, EP16E100110, P16C100018, EP16E100112, EP16ER100008, EP16ER100007, EP16E100113, EP16E110003, EP16E110001, EP16E110002, EP16E110004, and EP16E110005.
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela
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제품 설명
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. || The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution - USA (nationwide) and the country of Canada
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제품 설명
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
- 의료기기 분류등급
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의료기기 등급
3
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이식된 장치?
No
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유통
Worldwide Distribution - US Nationwide
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제품 설명
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 || Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
- Manufacturer