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
Articles - 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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Modèle / numéro de série
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Description du dispositif
Alert removed device pink brain medtech
- Manufacturer
- 1 Event
Fabricant
- Société-mère du fabricant (2017)
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Commentaire du fabricant
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
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Source
HA
6 dispositifs médicaux avec un nom similaire
En savoir plus sur les données ici
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Modèle / numéro de série
Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
No
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Distribution
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
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Description du dispositif
MEDTECH ROSA Brain 3.0 || The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
- Manufacturer
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: ROSA Brain 3.0.0 Robotic Surgical Assistant
- Manufacturer
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Modèle / numéro de série
ROSA Brain 3.0.0 | BR16027; BR16029
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Description du dispositif
MD: Neurological stereotactic surgery system
- Manufacturer
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Modèle / numéro de série
ROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ARTG Number: 235379
- Manufacturer
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Modèle / numéro de série
ROSA Brain and ROSA One Surgical RobotsROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ROSA One 3.1.0 Robotic Surgical AssistantSerial Number: BS16001ARTG Number: 235379 and 278903
- Manufacturer