456 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Promaxo MRI System
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
Forefoot Screws
FDA UDI
Life Spine, Inc.·00190837020408·
ARCHITECT C8000 PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·September 24, 2025
ARCHITECT C4000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·December 27, 2017
Pitkar External Fixation System - Rail Mechanism
FDA 510(k)
FDA Class 2
·Orthopedic
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
FDA 510(k)
FDA Class 2
·Physical Medicine
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 12, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·July 28, 2025
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Injury
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·September 11, 2025
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 30, 2025
PUMP MMT-1781K 670G V4.11 MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 10, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 3, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 2, 2025
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 11, 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·July 4, 2025
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 13, 2025
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 2, 2025