456 results · 23ms · Sources: EU EUDAMED, US FDA

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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