429 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OrthoNext Platform System
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM
VITREA 2, VERSION 2.1
FDA 510(k)
FDA Class 2
·Radiology
LDL CHOLESTEROL (AUTOMATED)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 30, 2025
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 21, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 16, 2025
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·September 16, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 11, 2025
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 8, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·July 28, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 23, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 15, 2025
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JPI·May 13, 2025
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·January 8, 2026
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 1, 2025
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 29, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 22, 2025
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 6, 2025
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 14, 2025