545 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EchoS Family
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
24M - Duke Energy FA/BBP
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015149·24M - Duke Energy FA/BBP
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CADHEALTH SYSTEM, MODEL CHP-001
FDA 510(k)
FDA Class 2
·Cardiovascular
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·December 11, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 15, 2025
MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 17, 2025
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 14, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 5, 2025
BD PHOENIX¿ NID
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·November 21, 2023
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 15, 2025
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 17, 2025
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 22, 2025
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 26, 2025
ALINITY I PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·September 22, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 22, 2025
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 11, 2025
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 16, 2025