494 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BrainInsight
FDA 510(k)
FDA Class 2
·Radiology
10M - General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
FDA 510(k)
FDA Class 2
·Neurology
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
FDA 510(k)
FDA Class 2
·General Hospital
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 26, 2024
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 17, 2024
PUMP MMT-1885A OUS BLE PUMP MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 7, 2024
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 29, 2024
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 3, 2025
I-STAT ACT KAOLIN CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JBP·May 7, 2024
640G INSULIN PUMP MMT-1711K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2024
640G INSULIN PUMP MMT-1711K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2024
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 6, 2024
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code MMI·October 29, 2024
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 2, 2024
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 7, 2024
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 23, 2024
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 1, 2024