13 results
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44ms
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Sources: EU EUDAMED, US FDA
Seers Medical LTd
Manufacturer
3 Importers
SEERS MEDICAL LTD
FDA registration
SEERS MEDICAL LTD·7 products·🇬🇧 United Kingdom
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Enforcement
Class II
·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Recall
Open, Classified
·SEER MEDICAL PTY LTD 278-284 Queensberry St Melbourne Australia·Product code GWQ·August 12, 2024
Lojer Oy
Importer
🇫🇮 Finland·5 Manufacturers
Camp Scandinavia Oy
Importer
🇫🇮 Finland·8 Manufacturers
Promedia A. Ahnfeldt GmbH
Importer
🇩🇪 Germany·7 Manufacturers
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
BLUE DEER MEDICAL EQUIPMENT (GUANGDONG) CO., LTD.
FDA registration
BLUE DEER MEDICAL EQUIPMENT (GUANGDONG) CO., LTD.·1 product·🇨🇳 China
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices