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)
The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Devices were distributed to 23 hospitals and medical centers throughout the US.
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제품 설명
Easy Access || Software releases 1.1, 5.2, 6.2 & 7.2
- Manufacturer
- 1 Event
제조사
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제조사 주소
Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
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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)
US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom
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제품 설명
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 || Product Usage: || Philips X-ray System
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.
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제품 설명
Philips Easy Diagnost Classic-Stationary x-ray system || Catalog Numbers: 70642, 70643, 706030, 706031, 706032 || Stationary x-ray system, Universal RF system for general use.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
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제품 설명
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose || Model: 712070. || The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.
- 의료기기 분류등급
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의료기기 등급
3
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이식된 장치?
No
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유통
Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
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제품 설명
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 || The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally
- 의료기기 분류등급
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의료기기 등급
3
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이식된 장치?
No
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유통
Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
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제품 설명
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. || The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
- Manufacturer